Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001463268
Ethics application status
Approved
Date submitted
23/08/2018
Date registered
30/08/2018
Date last updated
5/11/2019
Date data sharing statement initially provided
23/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Home-based occupational therapy for adults with both Down syndrome and dementia and their caregivers
Scientific title
Effectiveness of home-based occupational therapy to optimise performance in daily occupations for adults with both Down syndrome and dementia, and reduce caregiving strain for their informal caregivers: a single-case experimental design study
Secondary ID [1] 295761 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SCED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Down syndrome
309159 0
dementia 309160 0
Condition category
Condition code
Physical Medicine / Rehabilitation 308040 308040 0 0
Occupational therapy
Human Genetics and Inherited Disorders 308041 308041 0 0
Down's syndrome
Neurological 308302 308302 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Occupational therapy intervention process guided by a client-centred approach (Law, Baptiste, & Mills, 1995) will entail valuing occupational needs and goals important for the participants (Sumsion, 1993).
The occupational therapy intervention process will encompass seven stages adapted from the Occupational Performance Process Model (Fearing, Law, & Clark, 1997). Each stage will be tailored to meet the needs of the participants.
Baseline phase:
In the baseline phase, the first five stages of the Occupational Performance Process Model will be incorporated, which includes:
(1) Building rapport and identifying occupational goals with the participant with both Down syndrome and dementia and his/her informal caregiver(s). For this study, the ‘informal caregiver’ is an individual who provides care and support to their family member with dementia without receiving fee for his/her caregiving role (Farina et al., 2017).
(2) Choosing appropriate theoretical models and frames of reference to address specific occupational needs of the participants [e.g. Person-Environment-Occupational model (Law, 1996) and/or compensatory approach from the rehabilitation frame of reference (Seidel, 2003)and/or strength-based approach (Dunn et al., 2013)].
(3) Performing appropriate client-centred assessments to address the occupational needs of the participants. The client-centred assessment tools include: the American Occupational Therapy Association Occupational profile tool to understand the participant’s occupational performance history (American Association of Occupational Therapists, 2017), and the Canadian Occupational Performance Measure to identify and prioritise meaningful occupational goals (Law et al., 1990).
(4) From the gathered information, identifying strengths and available resources to address occupational goals of the participants.
(5) Negotiating achievable goals with the participants. The agreed occupational goals and time frame will be communicated both verbally and in written format to the participants.

Intervention (B) phase:
During the intervention phase, stage 6 of the Occupational Performance Process Model will be applied, which involves implementation of intervention/s tailored to meet the occupational goals of the participants.
For the participant with both Down syndrome and dementia, the interventions strategies will be broadly categorised into: education and training on task simplifications, task adaptations or use of equipment, and home modifications. For the informal caregiver(s), the intervention strategies will be broadly grouped into: communication and coping strategies, safe handling of the participant with both Down syndrome and dementia, use of equipment (and/or home modifications) to assist the participant with both Down syndrome and dementia, task simplification and adaptation, and providing information about available relevant external support networks.

Follow-up phase:
In the final stage (7) of the Occupational Performance Process Model, the identified goals of the participants will be re-evaluated, which will be as follows:
The DAD and the ZBI outcome measures will be completed via phone interviews on weekly basis. On the last session, independent assessor will also complete the COPM to evaluate if the goal has been accomplished.


Intervention delivered by: A qualified occupational therapist having a minimum of two years of clinical experience in neurological rehabilitation.

Independent assessor (a qualified therapist) will perform continuous assessments using outcome measures during baseline, intervention and follow-up phases.

Strategies to monitor adherence to occupational therapy intervention program:
Two possible strategies will be explored with the informal caregivers: (1) requesting informal caregiver(s) to document information in a diary, and/or (2) obtain verbal report from the informal caregiver(s) prior to start of each intervention session about the issues encountered whilst rehearsing home-program with participants' with both Down syndrome and dementia.

Mode of delivery: Face-to-face in the home environments and phone calls.

Number of times
Baseline phase: Minimum of three sessions (Weekly)
Intervention phase: Maximum of six sessions (Weekly).
Follow-up phase: Between 3 to 4 phone calls (Weekly).

References:
American Association of Occupational Therapists. (2017). AOTA Occupational Profile Template. American Journal of Occupational Therapy, 71(Supplement_2), 1. doi:10.5014/ajot.2017.716S12
Dunn, W.,Koenig, K.,Cox, J.,Sabata, D.,Pope, E.,Foster, L., & Blackwell, A. (2013). Harnessing strengths: daring to celebrate EVERYONE'S unique contributions, Part I. Developmental Disabilities Special Interest Section Quarterly, 36(1), 1-3. https://nyu-staging.pure.elsevier.com/en/publications/harnessing-strengths-daring-to-celebrate-everyones-unique-contrib-2
Farina, N.,Page, T. E.,Daley, S.,Brown, A.,Bowling, A.,Basset, T., . . . Banerjee, S. (2017). Factors associated with the quality of life of family carers of people with dementia: A systematic review. Alzheimer's & Dementia, 13(5), 572-581. doi:https://doi.org/10.1016/j.jalz.2016.12.010
Fearing, V.,Law, M., & Clark, J. (1997). An occupational performance process model: fostering client and therapist alliances. Canadian Journal of Occupational Therapy, 64(1), 7-15. doi:https://doi.org/10.1177/000841749706400103
Law, M. (1996). The person-environment occupation model: a transactive approach to occupational performance. Canadian Journal of Occupational Therapy, 63(1), 9-23. https://search.library.unisa.edu.au/record/UNISA_ALMA11161108200001831 doi:https://doi.org/10.1177/000841749606300103
Law, M.,Baptiste, S.,McColl, M.,Opzoomer, A.,Polatajko, H., & Pollock, N. (1990). The Canadian occupational performance measure: an outcome measure for occupational therapy. Canadian Journal of Occupational Therapy, 57(2), 82-87. doi:https://doi.org/10.1177/000841749005700207
Law, M.,Baptiste, S., & Mills, J. (1995). Client-centred practice: What does it mean and does it make a difference? Canadian Journal of Occupational Therapy, 62(5), 250-257. doi:https://doi.org/10.1177/000841749506200504
Seidel, A. (2003). Rehabilitation frame of reference. In Elizabeth B Crepeau, Ellen S Cohen, & Barbara A Boyt Schell (Eds.), Willard & Spackman's Occupational Therapy (pp. 238-240). Philadelphia: Lippincott Williams & Wilkins.
Sumsion, T. (1993). Client-centred practice: the true impact. Canadian Journal of Occupational Therapy, 60(1), 6-8. doi:https://doi.org/10.1177/000841749306000103
Intervention code [1] 312133 0
Rehabilitation
Comparator / control treatment
There is no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307085 0
For adults with both Down syndrome and dementia: Change in the level of performance in occupational performance areas (self-care, productivity and leisure) (Creek & Lawson-Porter, 2010) measured using the Disability Assessment for Dementia (Gélinas & Gauthier, 1994).
Timepoint [1] 307085 0
Baseline Phase: A minimum of three time points (Kratochwill et al., 2013) performed once a week. The potential length of baseline phase will be 3 weeks.
Intervention Phase: Maximum of six interventions will be provided once a week over six weeks period (week 4 to week 9-primary endpoint of interventions).
Follow-up phase: Three to four time points after intervention phase performed once a week (week 10 to week 12 or week 13).
Independent assessor will perform continuous assessments using outcome measures during baseline, intervention and follow-up phases.
Reference:
Kratochwill, T.,Hitchcock, J.,Horner, R.,Levin, J.,Odom, S.,Rindskopf, D., & Shadish, W. (2013). Single-case intervention research design standards. Remedial and Special Education, 34(1), 26-38. doi:10.1177/0741932512452794
Primary outcome [2] 307086 0
For informal caregivers of adults with both Down syndrome and dementia: Change in perceived caregiving strain measured using the Zarit Burden Interview scale (Bédard et al., 2001).
Timepoint [2] 307086 0
Baseline Phase: A minimum of three time points (Kratochwill et al., 2013) performed once a week. The potential length of baseline phase will be 3 weeks.
Intervention Phase: Maximum of six interventions will be provided once a week over six week’s period (week 4 to week 9-primary endpoint of interventions).
Follow-up phase: Three to four time points after intervention phase performed once a week (week 10 to week 12/week 13).
Independent assessor will perform continuous assessments using outcome measures during baseline, intervention and follow-up phases.
Reference:
Kratochwill, T.,Hitchcock, J.,Horner, R.,Levin, J.,Odom, S.,Rindskopf, D., & Shadish, W. (2013). Single-case intervention research design standards. Remedial and Special Education, 34(1), 26-38. doi:10.1177/0741932512452794
Secondary outcome [1] 350633 0
None
Timepoint [1] 350633 0
None

Eligibility
Key inclusion criteria
1) Inclusion criteria for participants with both Down syndrome and dementia:
-Confirmed medical diagnosis of both Down syndrome and dementia.
-Report of requiring assistance with daily activities, which includes self-care, productivity and leisure (Creek & Lawson-Porter, 2010).
-Living within the metropolitan area of Adelaide.
-Living in their own homes with their informal caregiver(s) or residing in close proximity to informal caregiver(s) who provide daily care and support.
-English speaking or if informal caregiver could speak English.
-Provides verbal consent to participate if capable.

2) Inclusion criteria for informal caregiver participants:
-Participants consider themselves as informal caregiver for the person with both Down syndrome and dementia.
-Who provide continuing daily care and support to their family member with both Down syndrome and dementia.
-English speaking.
-Consents to the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for participants with both Down syndrome and dementia :
-Pre-existing diagnosis of mental health issues (e.g. Depression or anxiety), as it may mask the clinical problems related to dementia..
-Having an active Occupational Therapy or Physiotherapy interventions for dementia prior to or during the study.
-Not living within the metropolitan area of Adelaide.
-Does not consent to the study.
2) Exclusion criteria for informal caregiver participants:
-Does not consent to the study.

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)
Not a randomised trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not a randomised trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
A-B-A Single-Case Experimental design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The total number of participants for this study will be six, which includes three participants with both Down syndrome and dementia and their informal caregivers. The rationale for three participants was drawn from single-case experimental design literature (Horner et al., 2005) and no specific calculation was completed.
The effectiveness of interventions will be established through performing visual graphical analysis (VGA). VGA will consist of analysis of data patterns within-phase (e.g. baseline phase or intervention phase) and between-adjacent phases (e.g. comparison of baseline and intervention phases) (Lane & Gast, 2014). For within-phase analysis, stability or variability of data points and change in trend will be determined using visual inspection of graphed data points (Portney & Watkins, 2015). For between-adjacent phases, change in level, trend, and latency will be analysed (Lane & Gast, 2014).
In addition, descriptive analysis will be used to describe the collected data.

References

Horner, R.,Carr, E.,Halle, J.,McGee, G.,Odom, S., & Wolery, M. (2005). The use of single-subject research to identify evidence-based practice in special education. Exceptional Children, 71(2), 165-179. doi:https://doi.org/10.1177/001440290507100203
Lane, J., & Gast, D. (2014). Visual analysis in single case experimental design studies: brief review and guidelines. Neuropsychological Rehabilitation, 24(3-4), 445-463. doi:10.1080/09602011.2013.815636
Portney, L., & Watkins, M. (2015). Single-subject designs. In L. Portney & M. Watkins (Eds.), Foundations of clinical research: Application to practice (pp. 235-276). Essex, United Kingdom: F A Davis. Retrieved from https://ebookcentral.proquest.com/lib/UNISA/reader.action?docID=4392815&ppg=256.




Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
14/01/2019
Actual
Date of last participant enrolment
Anticipated
5/11/2019
Actual
Date of last data collection
Anticipated
30/04/2020
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 300349 0
University
Name [1] 300349 0
University of South Australia
Country [1] 300349 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471, Adelaide, SA 5001
Country
Australia
Secondary sponsor category [1] 299848 0
None
Name [1] 299848 0
Address [1] 299848 0
Country [1] 299848 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301165 0
University of South Australia-Human Research Ethics Committee
Ethics committee address [1] 301165 0
Ethics committee country [1] 301165 0
Australia
Date submitted for ethics approval [1] 301165 0
14/08/2018
Approval date [1] 301165 0
13/11/2018
Ethics approval number [1] 301165 0
Application ID: 201342

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

Contacts
Principal investigator
Name 86066 0
Mrs Sujatha Raj
Address 86066 0
Playford Building (P4-18);City East campus
GPO Box 2471, Adelaide, SA 5001
Country 86066 0
Australia
Phone 86066 0
+ 61 8 830 21822
Fax 86066 0
Email 86066 0
[email protected]
Contact person for public queries
Name 86067 0
Sujatha Raj
Address 86067 0
Playford Building (P4-18);City East campus
GPO Box 2471, Adelaide, SA 5001
Country 86067 0
Australia
Phone 86067 0
+ 61 8 830 21822
Fax 86067 0
Email 86067 0
[email protected]
Contact person for scientific queries
Name 86068 0
Sujatha Raj
Address 86068 0
Playford Building (P4-18);City East campus
GPO Box 2471, Adelaide, SA 5001
Country 86068 0
Australia
Phone 86068 0
+ 61 8 830 21822
Fax 86068 0
Email 86068 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To maintain confidentiality of the participants.


What supporting documents are/will be available?

No Supporting Document Provided



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.