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Trial registered on ANZCTR
Registration number
ACTRN12626000940370p
Ethics application status
Not yet submitted
Date submitted
2/07/2026
Date registered
30/07/2026
Date last updated
30/07/2026
Date data sharing statement initially provided
30/07/2026
Type of registration
Prospectively registered
Titles & IDs
Public title
Feasibility testing the Help After Leaving hospiTal (HALT) rehabilitation program for older adults who have delirium in hospital.
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Scientific title
Feasibility and acceptability of a multidisciplinary, co-produced rehabilitation program to prevent decline after in-hospital delirium amongst older adults: Help After Leaving hospiTal (HALT).
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Additional trial identifiers [1]
317751
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2026/HRE00222
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Universal Trial Number (UTN)
U1111-1343-1920
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Trial acronym
HALT
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Related trial records
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Health condition
Health condition(s) studied:
Delirium
342665
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Condition category
Condition code
Neurological
338800
338800
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of the intervention or exposure
Participants who had delirium in hospital recently (and enrolled support people) will complete the HALT rehabilitation program. The HALT program is a series of up to eight modules designed to improve cognitive health and wellbeing through education and behaviour change following delirium. Modules will be selected for participants based on their preferences and an individual needs assessment conducted at baseline. Module topics include delirium education, medications, vision and hearing, cognitive engagement, sleep, wellbeing, nutrition and hydration, and physical functioning. Each module includes a minimum of 2, and up to 8 sessions, which will occur approximately weekly. A ninth module will be provided to the participant's support person (family, friend, or caregiver) and is specifically intended to offer education and support for caring for a person with delirium.
Modules will be delivered remotely via weekly phone calls or telehealth sessions (10–60 minutes) with a facilitator, guided by a printed resource booklet that is sent to participants. The printed resource booklets have been specifically developed for this project, and feedback on the resources will be part of the feasibility testing. All sessions are one-to-one, although support persons can be present with the deliirum patient (1 facilitator, 1 delirium patient, and 1 or more support persons present). Participants will complete the program from their place of residence. Facilitators will be allied health or nurses and trained in motivational interviewing techniques, which will be used to support patient-driven behaviour change. Session phone or video calls will include interactive behaviour change activities and may be supplemented by supportive email and text messages. The intervention will be delivered over approximately 4 weeks to 6 months, depending on the modules selected and participant schedules.
For this feasibility trial, the minimum completion requirement for all participants is completion of the first module, delirium education, which comprises two sessions space approximately 1 week apart. Therefore the minimum number of modules a participant can select is 1, and number of sessions is 2. The maximum number of modules a participant can select is 8 modules, and the total session number to complete all modules is 38. We do not anticipate many participants will wish/need to complete all 8 modules, however this will remain an option if desired. To maintain adherence, participants will be sent reminder texts or emails prior to their scheduled sessions, and the number of sessions attended is recorded as a feasibility outcome.
The facilitator for this feasiblity trial will be CIA Davis, who completed Motivational Interviewing training in 2020/2021 through a series of 5x3-hour workshops with Prof Jeff Breckon, a world leading expert and member of the Motivational Interviewing Network of Trainers. CIA Davis has helped co-produced the HALT program, module booklets and is writing a facilitator handbook. In future, all facilitators will attend a Motivational Interviewing training course, such as SA Healths Motivational Interviewing Online Module, at a cost of $66 for non-SA Health employees or free for SA Health employees. This course is a 3.5 hour online workshop. In additional they will be supported by the Facilitator Handbook (yet to be written).
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Intervention code [1]
334602
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Rehabilitation
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Intervention code [2]
334603
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Lifestyle
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Intervention code [3]
334731
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Behaviour
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Description of the comparator or control
This is a single-arm, pre–post, prospective feasibility trial of the HALT rehabilitation. All participants recieve the intervention (HALT program) as described above.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Recruitment rate - delirium patients (Primary feasibility outcome #1)
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Assessment method [1]
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Recruitment rate will be recorded in REDCap as the number of delirium patient-participants who are eligible after screening, sign consent and are given a StudyID (officially enrolled in the study).
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Timepoint [1]
346000
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Recruitment at end of enrolment period (6 months from opening of recruitment).
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Primary outcome [2]
346001
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Attrition rate (Primary feasibility outcome #2)
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Assessment method [2]
346001
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Attrition rate will be recorded in REDCap as the number of participants who withdraw from the study after enrolment. A participant is considered a withdrawal if they are given a studyID, but do not complete the delirium education module, or they complete this module but do not complete end of study assessments.
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Timepoint [2]
346001
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Attrition rate will be monitored for each participant in a prospective way, and the final rate (%) will be determined after all participants have completed the End of Study visit (4 weeks to 9 months after enrolment), or withdrawn.
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Primary outcome [3]
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Acceptibility (Primary acceptibility outcome #1)
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Assessment method [3]
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Qualitative Interviews. Qualitative interviews will be conducted at the end of study visit, and are anticipated to take around 30 minutes. They will be audio-recorded, and transcribed verbatim prior to analysis. They will be conducted by the study facilitator, and will be sem-structured guided by starter questions and prompts. Starter questions: - How did you find the HALT program? - What did you like about the program? - What did you dislike about the program? - Are there any ways you think it could be improved? - What did you think of the resource booklets? Prompts: - What made it easier to participate? - What made it harder to participate? - How could we improve the resource booklets? - Was there anything missing? - What could we have done differently? Additional question for the support persons: - Did you find the program helpful to yourself? If so, how? - Did you find the program helpful to your person? If so, how?
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Timepoint [3]
346181
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End of Study visit (after all selected/needed modules have been completed, (4 weeks to 9 months after enrolment)
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Secondary outcome [1]
464107
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Module completion rate (Primary feasibilty outcome #3)
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Assessment method [1]
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Each module selected at the study start, and then completed, will be recorded in REDCap. We will assess for each participant how many modules they originally wish to complete, and then how many modules are actually completed. A module will be considered complete when all sessions have been attended. For modules with 8 sessions, a module will be considered complete if at least 6/8 sessions are attended, as long as the final session is completed.
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Timepoint [1]
464107
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Assessed for each participant after they complete the End of Study visit (4 weeks to 9 months after enrolment). Final module completion rate will be determined after all participants have completed the End of Study visit or withdrawn.
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Secondary outcome [2]
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Time between hospital discharge and commencement (Primary feasibility outcome #4)
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Assessment method [2]
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Date of hospital discharge, and commencement date will be recorded in REDCap as part of screening and enrolment. Commencement occurs on the day of session 1 for the first module.
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Timepoint [2]
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Date of discharge to commencement date.
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Secondary outcome [3]
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Session attendance and duration (Primary feasibility outcome #5)
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Assessment method [3]
464912
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Each session attended will be recorded in REDCap, including start and end time to assess how long each session lasts. This is a composite outcome. Note this outcome is assessed independently of module completion rate. We are interested in how many sessions are attended, even if a module is not completed.
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Timepoint [3]
464912
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Final number of sessions attended, and mean duration, will be assessed for each participant after they have completed the study or withdrawn (between 4 weeks and 9 months after enrolment). Overall session attendance rate (%) and duration for the study will be determined after all participants have completed the study or withdrawn.
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Secondary outcome [4]
464913
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Total time to complete the program (Primary feasibility outcome #6)
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Assessment method [4]
464913
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Total time (in days) will be calculated from the commencement day (day of session 1), to the day of the final session (last session of last module). This will be calculated from the REDCap case report form which will track dates of all sessions attended.
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Timepoint [4]
464913
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Time from commencement to final session completed.
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Secondary outcome [5]
464914
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Reasons for withdrawal (Primary feasiblity outcome #7)
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Assessment method [5]
464914
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With the participants permission to retain their data after withdrawing, participants will complete a withdrawal form which will identify the main reason for their withdrawing. Withdrawal reasons will be classified as: - Health reasons (e.g. poor or declining health, new health challenge) - Personal circumstances changing (e.g. moving house) - Lack of efficacy (not seeing benefit of the program) - No longer willing to participate for any other reason - No reason given/reason unknown
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Timepoint [5]
464914
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Upon withdrawal from the study.
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Secondary outcome [6]
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Cognition (Secondary efficacy outcome #1)
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Assessment method [6]
464915
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Mini Addenbrookes Cognitive Examination-III total score Note maximum score is 30, and participants scoring <21 are excluded.
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Timepoint [6]
464915
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End of Study visit (4 weeks to 9 months after enrolment)
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Secondary outcome [7]
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Frailty (Secondary efficacy outcome #2)
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Assessment method [7]
464916
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Clinical Frailty Scale score
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Timepoint [7]
464916
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End of Study visit (4 weeks to 9 months after enrolment)
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Secondary outcome [8]
464917
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Physical functioning (Secondary efficacy outcome #3)
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Assessment method [8]
464917
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Acitivities of Daily Living CDI score (a combined score from Katz Index for Instrumental Activities of Daily Living and Lawton Scale for Basic Activities of Daily Living)
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Timepoint [8]
464917
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End of Study visit (4 weeks to 9 months after enrolment)
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Secondary outcome [9]
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Metabolic Equivalent Minutes of light, moderate and vigorous activities (Secondary efficacy outcome #4), as a composite outcome called "Physical activity level".
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Assessment method [9]
464918
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International Physical Activity Questionnaire - Elderly score
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Timepoint [9]
464918
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End of Study visit (4 weeks to 9 months after enrolment)
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Secondary outcome [10]
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Quality of life (Wellbeing) (Secondary efficacy outcome #5)
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Assessment method [10]
464919
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Euro-Quality of LIfe 5Dimension-5Level score
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Timepoint [10]
464919
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End of Study visit (4 weeks to 9 months after enrolment)
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Secondary outcome [11]
464923
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Loneliness (Wellbeing) (Secondary efficacy outcome #6)
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Assessment method [11]
464923
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University of California (LA) Three Item Loneliness Scale score
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Timepoint [11]
464923
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End of Study visit (4 weeks to 9 months after enrolment)
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Secondary outcome [12]
464926
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Depression (Wellbeing) (Secondary efficacy outcome #7)
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Assessment method [12]
464926
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Geriatric Depression Scale (short form) score
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Timepoint [12]
464926
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End of Study visit (4 weeks to 9 months after enrolment)
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Secondary outcome [13]
464933
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Sleep quality (Secondary efficacy outcome #8)
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Assessment method [13]
464933
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Brief Pittsburgh Sleep Quality Index score
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Timepoint [13]
464933
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End of Study visit (4 weeks to 9 months after enrolment)
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Secondary outcome [14]
464934
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Diet Quality (Secondary efficacy outcome #9)
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Assessment method [14]
464934
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Diet Quality Questionnaire - Australian version, all scores
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Timepoint [14]
464934
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End of Study visit (4 weeks to 9 months after enrolment)
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Secondary outcome [15]
464935
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Malnutrition status (Secondary efficacy outcome #10)
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Assessment method [15]
464935
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Mini Nutritional Assessment score
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Timepoint [15]
464935
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End of Study visit (4 weeks to 9 months after enrolment)
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Secondary outcome [16]
464936
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Carer burden, support person only
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Assessment method [16]
464936
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Zarit Burden Interview
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Timepoint [16]
464936
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End of Study visit (4 weeks to 9 months after enrolment)
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Eligibility
Key inclusion criteria
Delirium patients:
- Confirmed delirium during recent hospital stay (ideally within 1 month of starting the program)
- Recovered from delirium (don’t have delirium anymore)
- Aged 65–90 years (inclusive)
- Willing to modify health-related behaviours
- Willing to complete study assessments
- Able to speak and read conversational English
For the participant's support person, they must meet the following criteria:
- Aged 18 years or over
- A friend or family member who has face-to-face contact with the person who had delirium for at least an hour per week, for the next 12 months
- Willing to be a support person for the duration of the program
- Willing to complete study assessments
- Not diagnosed with clinical dementia (self-reported)
- Able to speak and read conversational English
- No severe vision or hearing loss
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Minimum age
65
Years
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Maximum age
90
Years
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Sex
Both males and females
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Healthy volunteers
No
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Key exclusion criteria
Delirium patient:
- Diagnosed with clinical dementia
- Presence of active delirium
- Diagnosed with terminal illness or receiving palliative care
- Does not speak/read English
- Severe vision or hearing loss
Support person:
- Diagnosed clinical dementia (self-reported)
- Unable to be a support person for the duration of the program
- Terminal illness
- Does not speak/read English
- Severe vision or hearing loss
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
To be considered a success, we will aim to recruit 40 delirium participants in 6 months, at least 75% of whom should complete the first module, and 60% of participants should complete at least 2 modules. A withdrawal rate of 25% or less will be considered successful.
Quantitative data outcomes including feasibility, efficacy and behaviour change outcomes will be assessed using relevant statistical methods. Continuous outcomes will be presented as means±SD or medians, and categorical variables as counts and percentages. Normality will be assessed, and either parametric (normal) or non-parametric (asymmetrical distribution) comparative tests will be used to compare pre-post outcome measures using with-in subject comparison. Analysis of variance will be used for continuous outcome comparisons, controlling for relevant demographic factors. As this is a pilot study, no power calculation has been done, and we may be under-powered to detect meaningful differences in behaviour change outcomes.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
14/06/2027
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Actual
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Date of last participant enrolment
Anticipated
13/12/2027
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Actual
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Date of last data collection
Anticipated
31/07/2028
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
29766
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment hospital [2]
29767
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Modbury Hospital - Modbury
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Recruitment hospital [3]
29885
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SA Health Urgent Care Hub – Sefton Park - Sefton Park
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Recruitment postcode(s) [1]
46112
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5112 - Elizabeth Vale
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Recruitment postcode(s) [2]
46113
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5092 - Modbury
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Recruitment postcode(s) [3]
46244
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5083 - Sefton Park
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Funding & Sponsors
Funding source category [1]
322292
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Charities/Societies/Foundations
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Name [1]
322292
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Northern Community Health & Research Foundation (Wellness and Ageing grant, 2025)
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Address [1]
322292
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Country [1]
322292
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Australia
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Primary sponsor type
University
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Name
Adelaide University
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Address
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Country
Australia
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Secondary sponsor category [1]
325226
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Government body
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Name [1]
325226
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Northern Adelaide Local Health Network (NALHN)
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Address [1]
325226
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Country [1]
325226
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Australia
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Secondary sponsor category [2]
325245
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Government body
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Name [2]
325245
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Central Adelaide Local Health Network (CALHN)
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Address [2]
325245
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Country [2]
325245
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Australia
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
320803
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Central Adelaide Local Health Network HREC
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Ethics committee address [1]
320803
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https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
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Ethics committee country [1]
320803
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Australia
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Date submitted for ethics approval [1]
320803
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03/08/2026
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Approval date [1]
320803
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Ethics approval number [1]
320803
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Summary
Brief summary
The purpose of the study is to pilot test the feasibility, acceptability, and efficacy of the HALT rehabilitation program among patients and their support persons leaving hospital after delirium. This study will employ a single-arm, pre–post feasibility trial of an education and behaviour change program, consisting of eight modules that cover major topics important for the participant's physical, cognitive, and mental health after delirium. Feasibility is assessed from recruitment and withdrawal rates, module uptake and module completion rates, time to complete the program and reasons for withdrawal. Acceptibility will come from interviews to understanding barriers and enablers to engagement and understanding perspectives of support persons on the program and their burden of care; and efficay will involve determining the effects on physical activity level, activities of daily living, diet quality, sleep quality, loneliness, mood, cognitive function, quality of life, and frailty.
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Trial website
https://cain.science/project/halt/
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Courtney Davis
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Address
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Adelaide University Magill Campus, St Bernards Rd, Magill SA 5072
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Country
151686
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Australia
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Phone
151686
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+61 8 8302 1417
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Fax
151686
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Email
151686
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[email protected]
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Contact person for public queries
Name
151687
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Courtney Davis
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Address
151687
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Office A2-29, Adelaide University Magill Campus, St Bernards Rd, Magill SA 5072
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Country
151687
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Australia
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Phone
151687
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+61 8 8302 1417
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Fax
151687
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Email
151687
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[email protected]
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Contact person for scientific queries
Name
151688
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Courtney Davis
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Address
151688
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Adelaide University Magill Campus, St Bernards Rd, Magill SA 5072
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Country
151688
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Australia
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Phone
151688
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+61 8 8302 1417
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Fax
151688
0
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Email
151688
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers
Conditions for requesting access:
•
Yes, conditions apply:
•
Requires approval by an ethics committee
What individual participant data might be shared?
•
De-identified individual participant data:
•
All outcomes data
What types of analyses could be done with individual participant data?
•
Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
•
Data repository:
Figshare (Licenced through Adelaide University), https://adelaide.figshare.com/
•
Email of trial custodian, sponsor or committee:
Request to the Chief Investigator (Courtney Davis),
[email protected]
Are there extra considerations when requesting access to individual participant data?
Yes:
In accordance with the Adelaide University’s Ownership and Retention of Data policy (2026), data from this clinical trial will be kept for at least 15 years post-publication. Hard copy data will be stored in a secure data repository. At the lapse of 15 years, hard copy data will be destroyed by fire or other permanent means. Digital data will be stored in departmental drives (located on Adelaide University servers) with password protection.
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Informed consent form
Participant Information Sheet and Consent Form
HALT_Stage 2_PICF_V1_30.06.2026.docx
Study protocol
HALT_Stage 2_Protocol_V1_13.07.2026.docx
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF