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Trial registered on ANZCTR


Trial ID
ACTRN12613001265763
Ethics application status
Approved
Date submitted
6/11/2013
Date registered
18/11/2013
Date last updated
18/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Dignity Therapy in Aged Care:A pilot study to determine feasibility and likely impact on residents and service providers
Scientific title
Dignity Therapy in Aged Care:A pilot study to determine feasibility and likely impact on residents and service providers
Secondary ID [1] 283412 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dignity in Aged Care 290322 0
Condition category
Condition code
Mental Health 290722 290722 0 0
Depression
Mental Health 290723 290723 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 - Dignity Therapy

Dignity Therapy involves 3 interviews during which the new resident is given the opportunity to reflect on important aspects of their lives, and how these experiences may benefit others. The first interview is face to face, approximately 1 hour long and audio recorded. The second interview is face to face, approximately 30 minutes long and is when the resident is able to edit the information obtained in the first interview. The third interview is face to face and approximately 15 minutes long when the resident is given the final document. This document is then made available to staff. In this study we are asking that the staff may be allowed to access the document so that they can refer to it when planning and delivering care.

One in three transcripts will be randomly selected by principal investigators and reviewed using the Dignity Therapy Adherence form. This will ensure adherence to the Dignity Therapy protocol and document deviations.

Dignity Therapy Intervention series of guided questions about a person's past life and events that are important to them. The interview is recorded, then edited, with a printed transcript as the end result. This transcript is, the generativity document or legacy, is designed to capture the essence of the person who was interviewed. The content of the document is the outcome of the following questions being asked -
"Tell me a little about your life history; particularly the parts that you either remember most, or are most important? When did you feel most alive?
* Are there things that you would want your family to know or remember about you?
* What are the most important roles you have played in your life (family, work, community service etc.)? Why were they important to you, and what did you accomplish?
* What are your most important accomplishments, and what makes you feel most proud?
* Are there things that you feel need to be said to your loved ones, or things that you would want to say again?
* What are your hopes and dreams for your loved ones?
* What have you learned about life that you want to pass along to others? What advice or guidance would you wish to pass along to your child(ren), husband, wife, parents, other(s)?
* Are there important words or instructions you would like to offer your family?
* In creating this permanent record, are there other things that you would like included?"
Intervention code [1] 288135 0
Other interventions
Comparator / control treatment
Arm 2 - Friendly Visit

Friendly Visiting involves the same number of visits as for Dignity Therapy but they are of shorter duration and do not consist of a formal interview. There is no document developed during the Friendly Visit.
Control group
Active

Outcomes
Primary outcome [1] 290724 0
Primary outcome 1 - Level of distress using the Patient Dignity Inventory.
Timepoint [1] 290724 0
Timepoint 1 - Baseline, 4 weeks and at 8 weeks post intervention
Secondary outcome [1] 305098 0
Secondary outcome 1 - level of depression measured using the Cornell Scale of Depression
Timepoint [1] 305098 0
Secondary timepoint - Baseline and at 8 weeks post intervention
Secondary outcome [2] 305099 0
Secondary outcome 2 - Quality of life using the Personal Wellbeing Index
Timepoint [2] 305099 0
Secondary timepoint 2 - Baseline, 4 weeks and 8 weeks post intervention

Eligibility
Key inclusion criteria
Eligible residents will:
1) Have a Psychogeriatric Assessment Scale – Cognitive Impairment Score (PAS-CIS) of 4 or less. A score of 4 or less indicates minimal impairment. This instrument is completed for all residents on admission into the RACF
2) Be a new admission to a RACF High Care bed of less than 2 weeks at time of enrolment
3) Not be in receipt of extra services,
4) Will need to speak and understand English
5) Not be at the end-of-life stage of life

Eligible staff will be permanent employees of the facilities delivering direct care to the residents receiving the intervention and / or involved in their care planning.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion:
1) residents who have cognitive impairment, ie PAS > 4
2) staff who have not delivered to / or planned care for the participating residents in the 4 weeks after the intervention was completed.

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



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Due to the small sample size for this pilot study analyses will be primarily descriptive, and any inferential statistics will be interpreted with caution as the study is not powered to detect clinically important effects.
All the tools will be tested for their feasibility in this setting as this information could inform a larger study.
The potential effectiveness will be measured through the comparison of outcomes for the intervention and comparison group.
Baseline levels will be used as covariates. Effect size estimates for both groups will be calculated. Mixed analysis of variance will be used to compare changes over time for the two groups. To measure acceptability, independent t-tests will be used to compare resident’s feedback on participating in the study. To measure feasibility, descriptive statistics will be used to report the number and percentage of visits by the research therapist, the time and duration of the therapy using means and standard deviations.
The IBM SPSS statistical software package version 20 will be used for data analysis.
Thematic analysis will be carried out to identify themes in the qualitative responses to open-ended questions, and management of the data will be undertaken using NVIVO software.
One in three transcripts will be randomly selected by principal investigators and reviewed using the Dignity Therapy Adherence form. This will ensure adherence to the Dignity Therapy protocol and document deviations.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 288138 0
University
Name [1] 288138 0
Curtin University
Address [1] 288138 0
School of Nursing and Midwifery
Kent Street, Bentley, WA 6102
Country [1] 288138 0
Australia
Funding source category [2] 288196 0
Government body
Name [2] 288196 0
Australian College of Nursing - Postgraduate Aged Care Scholarship
Address [2] 288196 0
1 Napier Close
Deakin, ACT 2600
Country [2] 288196 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
School of Nursing and Midwifery
Kent Street, Bentley, WA 6102
Country
Australia
Secondary sponsor category [1] 286855 0
Other
Name [1] 286855 0
Amana Living Inc (Aged Organisation)
Address [1] 286855 0
541 Hay Street,
Subiaco, WA, 6008
Country [1] 286855 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290051 0
Curtin University
Ethics committee address [1] 290051 0
School of Nursing and Midwifery
Kent Street, Bentley, WA 6102
Ethics committee country [1] 290051 0
Australia
Date submitted for ethics approval [1] 290051 0
Approval date [1] 290051 0
15/10/2013
Ethics approval number [1] 290051 0
HR 156/2013

Summary
Brief summary
Purpose of the study is to assess the usefulness and potential effectiveness of Dignity Therapy in reducing psychological and spiritual distress in newly admitted residents to Residential Aged Care Facilities (RACFs). The study will also assess the impact of the intervention on the service provider and care provision.
The intervention entails interviewing residents using a series of guided questions about their past life and events that are important to them and producing an edited document that could be shared with other family members and service providers.
A comparison group will receive another intervention (Friendly Visit).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43714 0
Prof Sama Aoun
Address 43714 0
School of Nursing and Midwifery
Curtin University,
Kent Street Bentley,
Perth WA 6102
Country 43714 0
Australia
Phone 43714 0
+61 8 9266 9293
Fax 43714 0
Email 43714 0
S.Aoun@curtin.edu.au
Contact person for public queries
Name 43715 0
Mrs Jo-Anne Coughlan
Address 43715 0
Amana Living Inc
c/- St Georges Home
2 Essex Street Bayswater, WA 6053
Country 43715 0
Australia
Phone 43715 0
+610429963501
Fax 43715 0
Email 43715 0
jacoughlan@amanaliving.com.au
Contact person for scientific queries
Name 43716 0
Mrs Jo-Anne coughlan
Address 43716 0
Amana Living Inc
c/- St Georges Home
2 Essex Street Bayswater, WA 6053
Country 43716 0
Australia
Phone 43716 0
+610429963506
Fax 43716 0
Email 43716 0
jacoughlan@amanaliving.com.au