- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06058754
Group-based [ADAPT] Versus One-to-one [Usual] Occupational Therapy (Go:OT Trial) (Go:OT)
Evaluating Group-based (ADAPT) Versus One-to-one (Usual) Occupational Therapy on Ability to Perform Activities of Daily Living (ADL) in People With Chronic Conditions (Go:OT Trial)
Study Overview
Status
Intervention / Treatment
Detailed Description
Background: The number of people living with chronic conditions limiting the ability to perform activities of daily living (ADL) tasks is increasing. Occupational therapists are trained to deliver interventions to improve ADL ability, e.g. by adapting and adjusting daily routines and physical environments. Municipality occupational therapy (OT) interventions are usually delivered as one-to-one sessions in the client´s home. While this intervention format might be effective in improving ADL ability, a group-based intervention format might be as effective but more cost-effective and hold other secondary gains. Guided by the British Medical Research Council's guidance (MRC) on how to develop and evaluate complex interventions, the ADAPT Program, a peer-exchange group-based program, was developed, piloted, and evaluated for its functioning and feasibility in municipality settings. These studies provided initial evidence for the ADAPT Programs effectiveness in improving ADL ability and suggests gains as improved well-being. Hence, the current phase concerns a full-scale evaluation of the ADAPT Program including evaluation of effectiveness, processes and cost-effectiveness.
Material and Methods: The randomized controlled trial (RCT), initiated with an external pilot (n=12), will include 130 home dwelling persons with decreased ADL ability following chronic conditions. Participants are randomized to either ADAPT Program (experimental) or usual OT (control).
Primary outcome: Observed ADL motor ability measured with the Assessment of Motor and Process Skills (AMPS).
Secondary outcomes: Observed ADL process ability measured with the AMPS; patient reported ADL task Performance and Satisfaction measured with the ADL-Interview (ADL-I, Performance and Satisfaction scores); Well-being assessed with the World Health Organisation-Five Well Being Index (WHO-5); Health-related Quality of Life assessed with the European Quality of Life - 5 Dimensions (EQ-5D).
Exploratory outcomes include patient reported changes, using transition scales to evaluate participants´ experience of a) changed ADL task performance and satisfaction, b) changed problem-solving skills, c) changed quality of life, d) changed global health, e) changed needs for assistance. Finally, participants are to rate their overall experience of the allocated occupational therapy intervention.
Data collection: Effectiveness and cost-effectiveness data are collected at baseline and post intervention i.e., 3-months (week 12) and 6-months (week 26) from baseline. Costs will be estimated based on micro costing and national registries. Effects will be Quality Adjusted Life Years and changes in AMPS ADL motor ability. Process evaluation data will be collected using registration forms and semi-structured qualitative interviews.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eva Wæhrens, Professor
- Phone Number: 38164166
- Email: eva.elisabet.waehrens@regionh.dk
Study Contact Backup
- Name: Cecilie von Bülow, PhD
- Phone Number: 38164147
- Email: Cecilie.von.bulow@regionh.dk
Study Locations
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-
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Frederiksberg, Denmark, 2000
- Recruiting
- The Parker Research Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Frederiksberg, Denmark
-
Contact:
- Eva Wæhrens
- Phone Number: 38 16 41 66
- Email: eva.elisabet.waehrens@regionh.dk
-
Contact:
- Cecilie von Bülow
- Phone Number: 38164147
- Email: Cecilie.von.bulow@regionh.dk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- ≥ one year since medical diagnosed with one or more chronic conditions.
- Lives in own home.
- Experience ADL task performance problems.
- Show ADL motor ability measures <1.50 logits on the AMPS ADL motor skill scale (indicate increased effort during ADL task performance).
- Communicate independently and relevantly orally and in writing.
- Willing and interested in attending occupational therapy interventions focused on improving ADL task performance.
Exclusion criteria:
- ADL process ability measures <0.00 indicating that the person is unlikely to profit from educational programs focused on using adaptational strategies.
- Personal ADL (PADL) problems with acute need for help.
- Mental illness and/or other acute (<3 months) conditions effecting ADL task performance significantly.
- Significant communication barriers (significant cognitive deficits, -aphasia, -hearing loss, -dyslexia and/or -language barriers).
- Known substance abuse.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ADAPT Program
The ADAPT Program is a structured and individualized group-based program
|
The ADAPT Program is a structured and individualized 10-week group-based program, in which two occupational therapists teach groups of people, the skills of problem-solving more efficiently as means to overcome ADL task performance problems.
The ADAPT Program 3.0 includes 2 individual two-hour sessions (sessions 1 and 10) conducted in the clients homes and eight two-hour group-based sessions (sessions 2-9).
Moreover, two booster sessions (sessions 11 and 12) are delivered to support sustainable gains after termination of the 10-week ADAPT Program 3.0
Other Names:
|
Active Comparator: Usual Occupational Therapy (UOT)
UOT is delivered by one occupational therapist in the clients homes or local environments. .
|
UOT is delivered by one occupational therapist.
Sessions are individualised and focused on improving ADL ability e.g. by practicing the performance of ADL task or adjusting home environments.
UOT typically includes 7 one-to-one sessions of 60 minutes, delivered over a 10-week period in the clients´ homes.
The dose is however not fixed but based on the occupational therapists´ clinical judgement in collaboration with the individual client
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in observed ADL motor ability, Assessment of Motor and Process Skills (AMPS)
Time Frame: week 12
|
Observation-based ADL motor ability (reflecting physical effort and independence ).
Linear measures of ADL motor ability generated using Rasch measurement models.
Higher scores mean better ADL ability
|
week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in observed ADL motor ability, using AMPS
Time Frame: week 26
|
Observation-based ADL motor ability (reflecting physical effort and independence ).
Linear measures of ADL motor ability generated using Rasch measurement models.
Higher scores mean better ADL ability
|
week 26
|
Change in observed ADL process ability, using AMPS
Time Frame: week 12
|
Observation-based ADL process ability (reflecting efficiency, safety and independence).
Linear measures of ADL process ability generated using Rasch measurement models.
Higher scores mean better ADL ability
|
week 12
|
Change in observed ADL process ability, using AMPS
Time Frame: week 26
|
Observation-based ADL process ability (reflecting efficiency, safety and independence).
Linear measures of ADL process ability generated using Rasch measurement models.
Higher scores mean better ADL ability
|
week 26
|
Change in self-reported ADL ability, using the ADL-Interview (ADL-I), Performance scale
Time Frame: week 12
|
Self-reported ability to perform ADL tasks, based on interview.
Linear measures of ADL ability generated using Rasch measurement models.
Higher scores mean better ADL ability
|
week 12
|
Change in self-reported ADL ability with ADL-I, Performance scale
Time Frame: week 26
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Self-reported ability ot perform ADL tasks, based on interview.
Linear measures of ADL ability generated using Rasch measurement models.
Higher scores mean better ADL ability
|
week 26
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Change in self-reported satisfaction with ADL ability, using ADL-I, Satisfaction scale
Time Frame: week 12
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Self-reported satisfaction with ADL task performance, based on interview.
Linear measures of ADL ability generated using Rasch measurement models.
Higher scores means higher satisfaction
|
week 12
|
Change in self-reported satisfaction with ADL ability, using the ADL-Interview (ADL-I), Satisfaction scale
Time Frame: week 26
|
Self-reported satisfaction with ADL task performance, based on interview.
Linear measures of ADL ability will be generated using Rasch measurement models.
Higher scores means higher satisfaction
|
week 26
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Well-being, using the World Health Organisation- Five Well-Being Index (WHO-5)
Time Frame: week 12
|
Participants are asked to rate well being in regard to five questions.
Response options are scored on a 6-point scale in which 0=at no time to 0=all the time.
Lower scores are lower well-being
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week 12
|
Well-being, using The World Health Organisation- Five Well-Being Index (WHO-5)
Time Frame: week 26
|
Participants are asked to rate well being in regard to five questions.
Response options are scored on a 6-point scale in which 0=at no time to 0=all the time.
Lower scores are lower well-being
|
week 26
|
Quality of life, using the EuroQoL 5 dimensions (EQ-5D)
Time Frame: week 12
|
Participants are asked to rate 5 aspects of health-related quality of life Quality of life in regard to five items scores on a 5 point likert scale from I am not/have none to I have extreme/i cannot
|
week 12
|
Quality of life, using EQ-5D
Time Frame: week 26
|
Participants are asked to rate 5 aspects of health-related quality of life Quality of life in regard to five items scores on a 5 point likert scale from I am not/have none to I have extreme/i cannot
|
week 26
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived change in ADL task performance, TRANS-Questionnaire
Time Frame: week 12
|
Participants are asked about their experienced change in a) performance of ADL tasks and b) satisfaction witt their ADL ability following occupational therapy intervention.
Response options are scored on a 7-point likert scale from 'markedly worse' to 'markedly better'
|
week 12
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Perceived change in ADL task performance, TRANS-Questionnaire
Time Frame: week 26
|
Participants are asked about their experienced change in a) performance of ADL tasks and b) satisfaction witt their ADL ability following occupational therapy intervention.
Response options are scored on a 7-point likert scale from 'markedly worse' to 'markedly better'
|
week 26
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Perceived change in problem-solving skills, TRANS-Questionnaire
Time Frame: week 12
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Participants are asked about their experienced change in a) identifying daily task performance problems and b) the ability to solve task performance problems following occupational therapy intervention.
Response options are scored on a 7-point likert scale from 'markedly worsened' to 'markedly better'
|
week 12
|
Perceived change in problem-solving skills, TRANS-Questionnaire
Time Frame: week 26
|
Participants are asked about their experienced change in a) identifying daily task performance problems and b) the ability to solve task performance problems following occupational therapy intervention.
Response options are scored on a 7-point likert scale from 'markedly worsened' to 'markedly better'
|
week 26
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Perceived change in Quality of Life, TRANS-Questionnaire
Time Frame: week 12
|
Participants are asked about their experienced change in a) overall functioning, b) mental well-being, c) physical well-being and d) social well-being following occupational therapy intervention.
Response options are scored on a 7-point likert scale from 'markedly bigger' to 'markedly less'
|
week 12
|
Perceived change in Quality of Life, TRANS-Questionnaire
Time Frame: week 26
|
Participants are asked about their experienced change in a) overall functioning, b) mental well-being, c) physical well-being and d) social well-being following occupational therapy intervention.
Response options are scored on a 7-point likert scale from 'markedly bigger' to 'markedly less'
|
week 26
|
Perceived change in global health, TRANS-Questionnaire
Time Frame: week 12
|
Participants are asked about their experienced change in global health following occupational therapy intervention.
Response options are scored on a 7-point likert scale from 'markedly worse' to 'markedly better'
|
week 12
|
Perceived change in global health, TRANS-Questionnaire
Time Frame: week 26
|
Participants are asked about their experienced change in global health following occupational therapy intervention.
Response options are scored on a 7-point likert scale from 'markedly worse' to 'markedly better'
|
week 26
|
Perceived change in assistance needed, TRANS-Questionnaire
Time Frame: week 12
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Participants are asked about their experienced change in needing assistance in a) findings ways to ease task performance, b) accepting my chronic condition, c) managing symptoms following occupational therapy intervention.
Response options are scored on a 7-point likert scale from 'markedly bigger' to 'markedly less'
|
week 12
|
Perceived change in assistance needed, TRANS-Questionnaire
Time Frame: week 26
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Participants are asked about their experienced change in needing assistance in a) findings ways to ease task performance, b) accepting my chronic condition, c) managing symptoms following occupational therapy intervention.
Response options are scored on a 7-point likert scale from 'markedly bigger' to 'markedly less' less
|
week 26
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Overall experience of the occupational therapy intervention
Time Frame: week 12
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Participants are asked to rate their experience on a 5 point Likert scale ranging from "excellent' to 'very poor'
|
week 12
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cecilie von Bülow, PhD, Parker Institute, Bispebjerg and Frederiksberg Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Parker Institute,
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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