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Trial registered on ANZCTR


Registration number
ACTRN12618000549224
Ethics application status
Approved
Date submitted
7/03/2018
Date registered
12/04/2018
Date last updated
7/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Dementia Lifestyle Coach: a pilot study of a support and coaching program for people recently diagnosed with early dementia
Scientific title
The Dementia Lifestyle Coach: a pilot study of a support and coaching program for people recently diagnosed with early dementia
Secondary ID [1] 294273 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 306959 0
Condition category
Condition code
Mental Health 306057 306057 0 0
Other mental health disorders
Neurological 306162 306162 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment Arms
This parallel group design will have an intervention group and a wait-list control group. The wait-list control group will receive the intervention after 6 months. A wait-list control group was selected rather than no-treatment control group because the study investigators considered it unethical to offer no support to participants, further offering the intervention to the control group would allow a greater sample with which to test acceptability of and fidelity to the intervention.

Intervention description
The Dementia Lifestyle Coach program is a 14 session psychoeducation, counselling and coaching program for people recently diagnosed with dementia. Sessions are hour-long and held weekly for the first 2 months, then fortnightly for 2 months, then monthly for the last 2 months (14 sessions in total). Sessions are face-to-face in an individual format and delivered by a registered psychologist or rehabilitation counsellor. In addition, participants receive support (monthly telephone conversations) from a trained peer who lives with dementia.

The research team has developed a program manual with aims, discussion topics and homework for program sessions.

The program is built on a frame of Acceptance Commitment Therapy (Hayes et al., 2006), and includes elements of positive psychology (Proyer et al., 2015) and coaching (Olsen and Nesbitt, 2010). Participants may choose in consultation with their counsellor to invite a family member or supporter to attend some of the sessions if this would support their adjustment to the diagnosis and implementation of lifestyle choices.

The program has 3 stages:
1) Adjusting to the diagnosis (sessions 1-6) – reframing what it means to have dementia
2) Living a good life (sessions 7-12) – values based living, goal setting, achieving at least 150 mins a week of physical, cognitive and social activity, referrals as appropriate for occupational therapy, speech pathology, cognitive rehabilitation or physiotherapy.
3) Planning for change (sessions 13-14) – emotional and practical strategies
Peer supporters living with dementia will be recruited through Dementia Australia and Dementia Alliance International. They will receive 8 hours of blended training including 3 hours face to face, 4 hours video conference, 1 hour readings and individual learning. The training will include the following topics: 'Establishing relationships and rapport'; 'Structure of the program'; 'Co-designing the peer support component of dementia lifestyle coach program'; 'Skills practice and role playing'; 'Intentional story telling”/active listening skills'; 'Stages of grief/managing grief/sadness'; 'Clinical and program procedures of the study'. Peer Supporters will also be supported through monthly meetings with peers and the research team and individual debriefing after every support conversation. Supporters will have a conversation (by telephone or in person) with the person with dementia each month in order to share their experiences.

Study records and peer supervision will be used to assess and maintain fidelity.
Intervention code [1] 300562 0
Treatment: Other
Intervention code [2] 300563 0
Lifestyle
Comparator / control treatment
The wait-list control group will receive the intervention after 6 months. A wait-list control group was selected rather than no-treatment control group because the study investigators considered it unethical to offer no support to participants, further offering the intervention to the control group would allow a greater sample with which to test acceptability of and fidelity to the intervention.
Control group
Active

Outcomes
Primary outcome [1] 305082 0
Number of participants with dementia recruited over the 18 month study. This outcome will be accessed using study records
Timepoint [1] 305082 0
18 months
Primary outcome [2] 305083 0
Number of participants retained over 18 month study. This outcome will be accessed using study records
Timepoint [2] 305083 0
18 months
Primary outcome [3] 305084 0
Number of counselling and coaching sessions received by participants with dementia. This outcome will be accessed using study records.
Timepoint [3] 305084 0
18 months
Secondary outcome [1] 344115 0
Number of peer support sessions received by participants with dementia. This outcome will be accessed using study records.
Timepoint [1] 344115 0
18 months
Secondary outcome [2] 344116 0
Fidelity of therapists to treatment manual. This is a primary outcome which will be assessed via the therapist notes.
Timepoint [2] 344116 0
18 months
Secondary outcome [3] 344582 0
Themes around acceptability and applicability to participants, and barriers and enablers to participation. This is a primary outcome which will be accessed through interviews and thematic analysis
Timepoint [3] 344582 0
18 months
Secondary outcome [4] 344583 0
Themes around positive and/or negative impacts of the Dementia Lifestyle Coach. This will be assessed though interviews and thematic analysis.
Timepoint [4] 344583 0
18 months
Secondary outcome [5] 344584 0
Difference between intervention and wait list-control group on quality of life. This will assessed through the QOL-AD (Orgeta et al., 2015) questionnaire
Timepoint [5] 344584 0
6 months and 12 months after randomisation
Secondary outcome [6] 344585 0
Difference between intervention and wait list-control group on efficacy. This will assessed through self-efficacy (Generalized Self-Efficacy Scale (Schwarzer and Jerusalem, 1995))
Timepoint [6] 344585 0
6 months and 12 months after randomisation
Secondary outcome [7] 344586 0
Difference between intervention and wait list-control group on cognitive function. This will be assessed using (ADAS-COG-plus (Skinner et al., 2012)) questionnaire
Timepoint [7] 344586 0
6 months and 12 months after randomisation
Secondary outcome [8] 344587 0
Difference between intervention and wait list-control group on physical function. This will be assessed using short physical performance battery and 6 minute walk.
Timepoint [8] 344587 0
6 months and 12 months after randomisation
Secondary outcome [9] 344588 0
Difference between intervention and wait list-control group on perceived and objective social support. This will be assessed using the Duke Social Support Index (Koenig et al., 1993).
Timepoint [9] 344588 0
6 months and 12 months after randomisation
Secondary outcome [10] 344589 0
Difference between intervention and wait list-control group on positive outlook. This will be assessed using the Flourishing Scale (Diener et al., 2010)
Timepoint [10] 344589 0
6 months and 12 months after randomisation
Secondary outcome [11] 344590 0
Difference between intervention and wait list-control group on depression. This will be assessed using the 15 item Geriatric Depression Scale (Yesavage et al., 1982).
Timepoint [11] 344590 0
6 months and 12 months after randomisation
Secondary outcome [12] 344591 0
Difference between intervention and wait list-control group on physical activity and sleep. This will be assessed using a fitbit worn for 1 week.
Timepoint [12] 344591 0
6 months and 12 months after randomisation
Secondary outcome [13] 344592 0
Difference between intervention and wait list-control group on level of physical, mental and social activities. This will be assessed using activity diaries.
Timepoint [13] 344592 0
6 months and 12 months after randomisation

Eligibility
Key inclusion criteria
• Received a diagnosis of any dementia within the preceding 6 months at point of application to the program
• Mini-mental State Examination (MMSE) score > 18 adjusted for age and education
• able to provide written consent to participate in the program
• able to keep written diaries, or has a co-habiting person willing to help record this information
• English speaking
• has home or mobile telephone
• not experiencing psychotic symptoms or suicidal
• not participating in another intervention study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Did not receive a diagnosis of any dementia within the preceding 6 months at point of application to the program
• Mini-mental State Examination (MMSE) score < 18 adjusted for age and education
• Unable to provide written consent to participate in the program
• Unable to keep written diaries, or has a co-habiting person willing to help record this information
• Non-English speaking
• Does not have home or mobile telephone
• Experiencing psychotic symptoms or suicidal
• Participating in another intervention study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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)
Simple randomisation using random number generator software (https://www.randomizer.org/). A list of 10 independent numbers between 1 and 20, Participants with these IDs will receive the intervention first.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This parallel group design will have an intervention group and a wait-list control group. The wait-list control group will receive the intervention after 6 months. A wait-list control group was selected rather than no-treatment control group because the study investigators considered it unethical to offer no support to participants, further offering the intervention to the control group would allow a greater sample with which to test acceptability of and fidelity to the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Estimation
The sample size of 20 will be adequate to test the feasibility of recruitment, delivery, and acceptability of the Dementia Lifestyle coach program, as well as appropriateness of instruments (Hertzog, 2008, Julious, 2005).

Population to be analysed
An intention-to-treat approach will be taken. Every participant enrolled in the trial will be included in the analysis, irrespective of therapy received, or availability of follow-up data.

Statistical Analysis Plan
Data will be entered into excel and analysed using SPSS.
Descriptive data will be presented separately for intervention and control groups on
a) Number of participants with dementia recruited, number of participants retained over 18 month study
b) Number of counselling and coaching sessions received by participants with dementia, number of peer support sessions received by participants with dementia, fidelity of therapists to treatment manual
c) Scales being trialled as outcome measures (mean, standard deviation, range, skewness and kurtosis, missing data), time taken to complete outcome measures
Differences between groups on change in outcome measures over the first 6 months of the study, and in the full 12 months will be analysed using linear mixed models. Bonferroni corrections will not be undertaken for multiple comparisons given the preliminary nature of these analyses.

Audio recordings of interviews with people with dementia, peer support workers and therapists will be transcribed. Qualitative data will be analysed using thematic analysis in an iterative process (Hsieh and Shannon, 2005). Nvivo software will be used to facilitate data analysis. One researcher will code preliminary themes and subthemes. A second researcher will independently code 20% of the material to ensure integrity of themes, any disagreement will be resolved through discussion to consensus of refinement of themes (involving a third researcher as needed). All material will be recoded according to the final set and definition of themes and subthemes.

DATA MANAGEMENT

Data Collection
Data will be collected through participant interviews.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/06/2018
Actual
Date of last participant enrolment
Anticipated
11/12/2018
Actual
Date of last data collection
Anticipated
11/06/2020
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 298910 0
University
Name [1] 298910 0
University of Sydney Faculty of Health Sciences Ageing and Health Research COMPACT
Country [1] 298910 0
Australia
Funding source category [2] 298913 0
Government body
Name [2] 298913 0
NHMRC Boosting Dementia Research Leadership Fellowship
Country [2] 298913 0
Australia
Funding source category [3] 299172 0
Government body
Name [3] 299172 0
NHMRC Boosting Dementia Research Leadership Fellowship
Country [3] 299172 0
Australia
Primary sponsor type
University
Name
University of Sydney, Faculty of Health Sciences Ageing and Health Research
Address
University of Sydney
Faculty of Health Sciences
Cumberland Campus
75 East Street,
Lidcombe New South Wales 2141
Country
Australia
Secondary sponsor category [1] 298430 0
None
Name [1] 298430 0
Address [1] 298430 0
Country [1] 298430 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299852 0
University of Sydney
Ethics committee address [1] 299852 0
Ethics committee country [1] 299852 0
Australia
Date submitted for ethics approval [1] 299852 0
14/11/2017
Approval date [1] 299852 0
15/12/2017
Ethics approval number [1] 299852 0
2017/962

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

Contacts
Principal investigator
Name 81774 0
Prof Lee-Fay Low
Address 81774 0
Faculty of Health Sciences
University of Sydney
Cumberland Campus
75 East St, Lidcombe
NSW 2141
Country 81774 0
Australia
Phone 81774 0
+61 2 9036 7368
Fax 81774 0
Email 81774 0
lee-fay.low@sydney.edu.au
Contact person for public queries
Name 81775 0
Annica Barcenilla-Wong
Address 81775 0
University of Sydney
Faculty of Health Sciences
Cumberland Campus
75 East St, Lidcombe
NSW 2141
Country 81775 0
Australia
Phone 81775 0
+61 2 9351 9837
Fax 81775 0
Email 81775 0
annica.barcenilla@sydney.edu.au
Contact person for scientific queries
Name 81776 0
Annica Barcenilla-Wong
Address 81776 0
Faculty of Health Sciences
University of Sydney
Cumberland Campus
75 East St, Lidcombe
NSW 2141
Country 81776 0
Australia
Phone 81776 0
+61 2 9351 9837
Fax 81776 0
Email 81776 0
annica.barcenilla@sydney.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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