Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000926730p
Ethics application status
Submitted, not yet approved
Date submitted
23/06/2022
Date registered
29/06/2022
Date last updated
29/06/2022
Date data sharing statement initially provided
29/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Frailty Reduction via Implementation of Exercise, Nutritional support and Deprescribing Project: The FRIEND Project
Scientific title
Frailty Reduction via Implementation of Exercise, Nutritional support and Deprescribing Project: The FRIEND Project - Pilot implementation study in older adults with mild cognitive impairment or dementia
Secondary ID [1] 307371 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FRIEND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
frailty 326682 0
cognitive impairment 326684 0
Condition category
Condition code
Musculoskeletal 323924 323924 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 323925 323925 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves the delivery of a multicomponent intervention which aims to reduce frailty in residents of aged care living with Mild Cognitive Impairment or Dementia.

FRIEND intervention components:
Individualised treatment plan for the reduction of frailty:
As part of the study, the research team including the study geriatrician, dietitian, exercise physiologist, and pharmacist will work together with the Clinical Nurse Manager and relevant staff members at TGSH, including the resident’s general practitioner (GP), to design individualised treatment plans for the residents that aim to reduce frailty via the implementation of an exercise, nutritional support and medication review intervention.

1. Exercise component of the FRIEND intervention:
Targeted residents will attend two strength and balance exercise training session per week. Sessions will be delivered in a purpose-built gym at TGSH and supervised by an Accredited Exercise Physiologist with a ratio of 1:1 to 1:3 depending on level of cognition and function. Session duration will be approximately 60 minutes. Specific resistance exercises critical for mobility and function will include leg press, knee extension, hip abduction, triceps, seated row, and chest press. Additional balance exercises will also be prescribed which include variations of static standing positions (tandem, semi-tandem) and dynamic balance (tandem walking within parallel bars). Intensity will be monitored via participant and assessor-rated ratings of perceived exertion (RPE) and will increase over the first 2 weeks to about 80% of peak capacity, and continuous progression will ensure intensity remains high throughout the intervention period.

2. Nutritional component of the FRIEND intervention:
Targeted residents will undergo a detailed assessment of their nutritional status and receive individualised nutritional support. This assessment will involve the completion (with assistance if necessary) of the Mini-nutritional assessment, along with a review of dietary intake and practices by liaising with facility food preparation staff and logs. The nutritional support includes the removal of unnecessary or potentially harmful dietary restrictions that may increase the risk of unintentional weight loss or increase the risk of malnutrition. The research team (including an nutritionist) will review the food/nutrient-drug interactions and exercise-diet interactions and advise the GP when possible, on the potential deprescription or dose reduction of any medication known to cause sedation, constipation, nausea, vomiting, anorexia, and/or diarrhoea. Supplementation of vitamin D will also be included in the nutrition support were indicated after assessment by the participant’s treating GP. Toincrease protein intake and enhance skeletal muscle synthesis a high protein snack will be provided after the exercise sessions and potentially at other times if needed. Nutritional recommendations will be made to the staff and family of residents with malnutrition to increase nutrient density and improve nutritional status. To increase appetite, when possible, exercise will be performed 1 hour prior to a meal to stimulate appetite, and/or walking for at least 5-10 minutes before meals when possible will be encouraged. Enhancement of the aesthetic aspects of food preparation and service and increased mealtime socialisation will be used to promote dietary intake. All of these changes will occur through collaboration with the facility and food preparation staff, who will implement these changes in practice with the consent of the individual.

3. Medication review: A complete drug audit will be carried out at baseline and monthly intervals. This information will be ascertained by reviewing facility records, liaising with the participant's medical team where necessary for further information, and also through in-person interviewing and assessing the participant (the latter to ascertain symptoms, goals, etc.). Established algorithms will be used to identify excess dosages, drugs without sufficient indication, and potentially inappropriate medications (based on BEERS list, STOPP protocols, anticholinergic burden, etc.). GPs will be sent a summary of recommendations based on these audits, including rationale and suggestions for deprescribing strategies. Particular emphasis will be placed on drugs with adverse effects on cognition, appetite, and mobility. Continuous monitoring for any adverse effects of discontinued or reduced dosages of medications will be undertaken by nursing staff and reported to GPs if necessary. The in-person interview will take place as part of the initial assessment and be no longer than 30 minutes at baseline for each resident participant, with case conferences held each month with the care team and study investigators to review progress.

4. Educational component of the FRIEND intervention:
Educational modules for residents and families (face-to-face), as well as pharmacy, nursing, GPs, and other relevant staff (online modules) will be delivered to educate on the role that exercise, nutrition and deprescribing has on reducing frailty and improving resident’s overall health. The education modules will be developed specifically for this study to build a comprehensive understanding of best-practice frailty intervention in aged care.

The educational modules for staff will include a general module (completed by all), followed by more specific and detailed modules on nutrition, exercise, and medication optimisation respectively, which will be assigned based on the role of the worker in relation to the participants (i.e. a chef will complete the general module, as well as the nutrition module. Conversely a nurse will complete the general module, plus the three specific modules due to their holistic role with the participants). Modules will consist of recorded lecture content (screen of presentation + talking head) specifically developed and adapted for the target audience presented in discrete chunks to improve engagement. Accompanying this lecture content will be instructional videos (when appropriate, such as 'how to' for performing various exercises), simple fact sheets summarising content, and a more comprehensive procedural document (for staff performing the various aspects of the intervention). All of these content will be accessed via a dedicated, encrypted website which securely links to the Redcap database. The general module is expected to take around an hour, while each specific module around 2-3 hours. A knowledge quiz will be completed prior to undertaking the modules, immediately after taking the modules, and then at the completion of the 6-month intervention.

Caregivers participants will also complete quizzes (adapted for lay audience) pre and post module delivery, and after 6 months, however will only complete a general module which has specifically adapted for a lay audience. This module will last 1-2 hours.

Resident participants will receive a simplified knowledge quiz before and after the delivery of a face-to-face resident talk delivered by the study intervention team lasting for 30-60mins.

All of the education modules will take place at baseline prior to the commencement of the 6-month nutrition, exercise and deprescribing intervention over a two week period.

Adherence and fidelity to both the educational modules and intervention components will be monitored via online completion of activities (education modules), and via routine data entry throughout the 6-month evaluation period (clinical case notes, dosage reports, redcap data entry, monthly case conference information).
Intervention code [1] 323803 0
Rehabilitation
Intervention code [2] 323804 0
Lifestyle
Intervention code [3] 323805 0
Behaviour
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331731 0
Primary Effectiveness outcome: The FRAIL-NH scale for frailty
Timepoint [1] 331731 0
Baseline and 6-months after enrolment
Secondary outcome [1] 410935 0
Implementation: Acceptability (measured via Semi-structured interviews with staff members, residents, and family members/ informal caregivers)
Timepoint [1] 410935 0
6-months after enrolment (post intervention)
Secondary outcome [2] 410936 0
Implementation: Adoption (measured via Number of staff, residents and family members/ informal caregivers who undertake the education al training modules). Data collected via submission from website to redcap and website login data.
Timepoint [2] 410936 0
Baseline and 6 months after enrolment (post-intervention)
Secondary outcome [3] 410937 0
Implementation; Adoption (measured via questionnaire designed for study on experience of training and applicability of the skills learned – Administered to staff, residents, and family members/ informal caregivers.)
Timepoint [3] 410937 0
After completion of educational training modules at baseline after enrolment
Secondary outcome [4] 410938 0
Implementation: Adoption (Measured through Practice change via the Implementation Behaviour Survey and Alberta Context Tool Survey– Administered to staff members)
Timepoint [4] 410938 0
6-months after enrolment (post-intervention)
Secondary outcome [5] 410939 0
Implementation: Adoption (Measured via Audit of intervention components delivered and resident adherence to the intervention components evaluated using self-designed intervention logs)
Timepoint [5] 410939 0
Monthly, from baseline through to 6-months after enrolment
Secondary outcome [6] 410942 0
Implementation - Adoption: Influences on uptake, integration and routinisation (roles, relations, context, value systems, barriers/enablers) - Measured via Focus groups with managerial and senior representatives of TGSH
Timepoint [6] 410942 0
Planning phase (pre-implementation before baseline enrolment) and Evaluation phase (post-implementation at 6-months after enrolment)
Secondary outcome [7] 410943 0
Implementation - Adoption: Influences on uptake, integration and routinisation (roles, relations, context, value systems, barriers/enablers) - Measured via Monthly implementation team meeting notes)
Timepoint [7] 410943 0
Monthly, from baseline through to 6-months after enrolment
Secondary outcome [8] 410944 0
Implementation - Adoption: Influences on uptake, integration and routinisation (roles, relations, context, value systems, barriers/enablers) - Measured via Semi-structured interviews with managerial staff and health care staff
Timepoint [8] 410944 0
6-months after enrolment (post-intervention)
Secondary outcome [9] 410945 0
Implementation: Fidelity - measured via fidelity checks with research and staff members involved in the delivery of the intervention using self-designed fidelity checklist
Timepoint [9] 410945 0
Monthly, from baseline through to 6-months after enrolment
Secondary outcome [10] 410946 0
Implementation: Knowledge Transfer - measured via Pre- and post-training knowledge acquisition quiz administered to staff, residents, and informal caregivers
Timepoint [10] 410946 0
Prior to delivery of modules at baseline enrolment, immediately after module delivery at baseline, and at 6-months after enrolment (post-intervention)
Secondary outcome [11] 410947 0
Implementation: Fidelity - measured via Focus group discussions with consumer and consumer representatives, health care professionals and stakeholders to provide feedback on the content of the FRIEND project website which will be used for ongoing refinement
Timepoint [11] 410947 0
6-months after enrolment (post-intervention)
Secondary outcome [12] 410948 0
Implementation: Cost of service implementation (Calculation of the cost involved with delivering the FRIEND intervention components (staff time, resources required). Data on salary will be collected from position descriptions and salary gradings for involved staff and an audit of the hours each staff member is involved in direct facilitation of the study components. Informal care provided by volunteers and caregivers will be calculated via audit of study logs and calculated based upon award rates for aged care carer position.
Timepoint [12] 410948 0
Monthly, from baseline through to 6-months after enrolment
Secondary outcome [13] 410949 0
Nutritional Status measured via Mini Nutritional Assessments (MNA) using participants self-report and extracting meal data from food preparation software. Measurements including weight (calibrated chair scale), height (knee heigh formula using tape measure), mid-arm and calf circumferences (by tape measure) will be taken by study investigators from baseline and 6-month after enrolment time points.
Timepoint [13] 410949 0
All measurements - at baseline and at 6-months after enrolment (post-intervention).
Weight - Monthly, from baseline through to 6-months after enrolment (post-intervention)
Secondary outcome [14] 410950 0
Medication audit [Medication count and use of potentially inappropriate medications (PIMs)] extracted from data-linkage to medical records in the facility.

Timepoint [14] 410950 0
Monthly, from baseline through to 6-months after enrolment (post-intervention)
Secondary outcome [15] 410951 0
Functional mobility - Six-minute Walk Test (6MWT)
Timepoint [15] 410951 0
baseline and at 6-months after enrolment (post-intervention)
Secondary outcome [16] 410952 0
Functional Mobility - Short Physical Performance Battery (SPPB)
Timepoint [16] 410952 0
baseline and at 6-months after enrolment (post-intervention)
Secondary outcome [17] 410953 0
Maximal dynamic muscle strength - One-Repetition Maximum - Leg press
Timepoint [17] 410953 0
At baseline and at 6-months after enrolment (post-intervention)
Secondary outcome [18] 410954 0
Maximal dynamic muscle strength - One-Repetition Maximum - Knee Extension
Timepoint [18] 410954 0
At baseline and at 6-months after enrolment (post-intervention)
Secondary outcome [19] 410955 0
Quality of Life (measure via Quality of Life-Alzheimer’s Disease scale (QoL- AD scale)
Timepoint [19] 410955 0
At baseline and at 6-months after enrolment (post-intervention)
Secondary outcome [20] 410956 0
Cognitive function measured via Montreal Cognitive Assessment (MoCA)
Timepoint [20] 410956 0
At baseline and at 6-months after enrolment (post-intervention)
Secondary outcome [21] 410957 0
Depressive symptoms measured via Cornell Scale for Depression in Dementia (CSDD)
Timepoint [21] 410957 0
At baseline and at 6-months after enrolment (post-intervention)
Secondary outcome [22] 410959 0
Ongoing health status (New medical diagnosis or new (or change) in symptoms
Timepoint [22] 410959 0
Weekly throughout the study period (weekly status check questionnaire)
Secondary outcome [23] 410960 0
Ongoing medical status Adverse events gathered from a weekly health check questionnaire and extracting data from facility files. Examples include, but are not limited to, falls, injurious falls, drug-related adverse events, infection, delirium, Joint sprain, Muscle strain, skin tear, pressure sores, etc.
Timepoint [23] 410960 0
Weekly throughout the study period (weekly status check questionnaire); and daily as reported by the Care Team at TGSH as part of their usual care practices
Secondary outcome [24] 411282 0
Ongoing medial status - New (or change) in medications gathered from a weekly health check questionnaire and extracting data from facility files.
Timepoint [24] 411282 0
Weekly throughout the study period (weekly status check questionnaire)
Secondary outcome [25] 411284 0
Ongoing medical status visits to health care practitioners gathered using a weekly health check questionnaire and extracting data from facility files.
Timepoint [25] 411284 0
Weekly throughout the study period (weekly status check questionnaire)

Eligibility
Key inclusion criteria
Residents of TGSH:
Inclusion criteria: Men and women, age 60 or above, presence of cognitive impairment or dementia (Montreal Cognitive Assessment Tool (MoCA) score <26/30), presence of frailty (frailty status Frail-NH Scale score >1/14), able to understand written and spoken English

Family member/ informal caregivers of participating residents (only if available- not mandatory):
Inclusion criteria: Men and women, age 18 or above, able to read and converse in English, able to visit their loved one at TGSH at least monthly throughout the duration of the study, willing to support their loved one during their participation in the study by: a) accompanying him/her during the study initial screening visit; b) attending an educational program relating to the management of frailty and completing a pre- and post-knowledge questionnaire; and c) attending a monthly 30-minute case conference case conferences at TGSH.

• Staff members from TGSH:
Inclusion criteria: Men and women, employed by TGSH in a role related to the provision of care for the
participating residents, fluent English speaker
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Residents of TGSH:
Exclusion criteria: Have permanent medical contraindications to the planned exercise due to unstable or terminal disease, unable to speak or understand insructions provided in English language, bed- bound, planning to relocate to a different area within the facility, or to a different facility within 7 months of study enrolment


Family member/ informal caregivers of participating residents (only if available- not mandatory):
Exclusion criteria: Unable to speak and understand English language at a conversational level.

• Staff members from TGSH:
Exclusion criteria: Unable to speak and understand instructions provided in English language.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is a single group pilot implementation research study employing a mixed methods research design to evaluate the process of- and impact of- implementation of the FRIEND Project in a residential aged care facility (RACF).
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Quantitative analysis:
All quantitative data will be entered into SPSS. Baseline sample characteristics will be presented using descriptive statistics (mean and standard deviation). One way ANOVA will be conducted to compare baseline study participant characteristics to the facility wide audit data. Intervention outcome measures will be analysed via repeated measures LMM or GLMM as appropriate to the distribution of the data of baseline and 6-month time points, adjusted for baseline values and all covariates selected a priori (age, sex, education) as well as any additional potential confounders associated with the dependent variable of interest identified. Mixed models will be constructed to determine the TIME effect. We will report estimated marginal means (95% CIs), mean differences between timepoints and Hedges’ bias corrected effect sizes (95% CIs) for all outcomes and accept significance at the 5% level.

Qualitative analysis:
Focus groups and interviews conducted with staff members, residents and their informal caregivers will be audio-recorded, transcribed verbatim and entered into QSR NVivo. Thematic analysis (developing codes) will be used to identify patterns within the study groups. A combination of inductive and deductive coding will be used. For residents and informal caregivers coding will commence with experience of the FRIEND program and perceptions of change but will be open to unexpected findings that may contribute to these. For staff members, frameworks focusing on implementation and organisational culture will assist to synthesise the data gathered in order to build a comprehensive assessment of the barriers and facilitators; and thus informing implementation.

Implementation outcomes:
Evaluation of implementation outcomes will be guided by the framework of Normalisation Process Theory (NPT) and seek to understand how the intervention can be made workable and integrated into the organisational environment. NPT will be utilised to identify and explain the factors that contribute to adoption of FRIEND. Four key components of NPT will be used to inform implementation (including training provided), and evaluation (data collection and analysis): (i) Coherence (how do Nurses, Allied Health Professionals (AHPs) and General Practitioners (GPs) make sense of the intervention within the care they provide to residents; (ii) Cognitive Participation (will health care staff of the RACF have a commitment to implementing the intervention; (iii) Collective Action (what is the work required to ensure the intervention is implemented; and Reflective Monitoring (how will we appraise the benefits and costs of the intervention).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
Date of last participant enrolment
Anticipated
31/08/2022
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 37832 0
4814 - Annandale

Funding & Sponsors
Funding source category [1] 311654 0
Government body
Name [1] 311654 0
Dementia Centre for Research Collaboration (DCRC)
Country [1] 311654 0
Australia
Funding source category [2] 311660 0
University
Name [2] 311660 0
James Cook University Chiropractic Research Grant
Country [2] 311660 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 313107 0
None
Name [1] 313107 0
Address [1] 313107 0
Country [1] 313107 0
Other collaborator category [1] 282331 0
University
Name [1] 282331 0
James Cook University
Address [1] 282331 0
1 James Cook Drive, Douglas, QLD, 4814
Country [1] 282331 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311110 0
University of Sydne HREC 1
Ethics committee address [1] 311110 0
Ethics committee country [1] 311110 0
Australia
Date submitted for ethics approval [1] 311110 0
28/03/2022
Approval date [1] 311110 0
Ethics approval number [1] 311110 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119974 0
Dr Trinidad Valenzuela
Address 119974 0
University of Sydney
Faculty of Medicine and Health
Discipline of Exercise and Sport Science
D18- Susan Wakil Health Building
Camperdown NSW 2006
Country 119974 0
Australia
Phone 119974 0
+61 0435 395 227
Fax 119974 0
Email 119974 0
t.valenzuela@sydney.edu.au
Contact person for public queries
Name 119975 0
Maria Fiatarone Singh
Address 119975 0
University of Sydney
Faculty of Medicine and Health
Discipline of Exercise and Sport Science
D18- Susan Wakil Health Building
Camperdown NSW 2006
Country 119975 0
Australia
Phone 119975 0
+61 2 9351 9755
Fax 119975 0
Email 119975 0
maria.fiataronesingh@sydney.edu.au
Contact person for scientific queries
Name 119976 0
Maria Fiatarone Singh
Address 119976 0
University of Sydney
Faculty of Medicine and Health
Discipline of Exercise and Sport Science
D18- Susan Wakil Health Building
Camperdown NSW 2006
Country 119976 0
Australia
Phone 119976 0
+61 2 9351 9755
Fax 119976 0
Email 119976 0
maria.fiataronesingh@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not at this time as participant data will be drawn from a small, particular section of the facility which makes it difficult to truly de-identify.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16414Study protocol    The study protocol document will be uploaded pendi... [More Details]



Results publications and other study-related documents

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