Group-based [ADAPT] Versus One-to-one [Usual] Occupational Therapy: A Pilot and Feasibility Study
- Conditions
- Chronic Conditions, MultipleChronic Condition
- Interventions
- Other: UOTOther: ADAPT program
- Registration Number
- NCT05775653
- Lead Sponsor
- Parker Research Institute
- Brief Summary
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. Municipality occupational therapy interventions are usually delivered as one-to-one sessions in the client´s home. While this intervention format might be effective, a group-based intervention format might be as effective but more cost-effective? Hence, the group-based ADAPT program was developed, piloted and evaluated for its functioning and feasibility in municipality settings. These studies provided initial evidence for the ADAPT Programs effectiveness. A randomized controlled trial (RCT) is however needed to document effectiveness, processes, and cost-effectiveness of the ADAPT program versus usual occupational therapy (UOT) for people with chronic conditions. Prior to the RCT, this pilot and feasibility study will be conducted to test aspects of trial design, conduct and processes as well as intervention content and delivery.
Material and Methods: A total of 16 home dwelling persons with chronic conditions, experiencing ADL task performance problems will be randomized and allocated to receive ADAPT (intervention) or UOT (control). Effectiveness and cost-effectiveness assessments are collected at baseline and post intervention i.e., 3-months (week 12) and 6-months (week 26) from baseline. Pilot and feasibility aspects will be evaluated by means of registrations forms filled out by the OTs delivering ADAPT and people with chronic conditions attending ADAPT. Registrations are designed to inform aspects of 1) recruitment and retention, 2) trial participation, 3) impact of trial on participants and staff, 4) completion rates, 5) fidelity and dose 6) assesable information and 7) adaptation of trial conduct to local context. Progression criteria for when to 'go', 'amend' or 'be alert/stop' are defined, to support the decision on whether to continue to RCT or the need to adjust design or procedures,
- Detailed Description
TThe specific aims of this pilot and feasibility study are to evaluate:
1. how recruitment procedures work and if participants accept randomization (recruitment and retention)
2. if clients feel adequately informed about the purpose of the assessments done and the content and time use regarding interventions delivered (trial participation)
3. if trial participation has unanticipated impacts on ADAPT OTs (e.g. workload) (Impact of trial on staff)
4. if registration forms and outcome measurements are completed (Completion rates)
5. the extent of which the ADAPT OT adhere to the ADAPT program manual and deliver key components within each session (fidelity and dose)
6. if data informing about intervention delivered in UOT is accessible from client records (Assessable information)
7. if ADAPT OTs perceive organizational factors to facilitate or hinder program delivery (adaptation of trial conduct to local context)?
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- ≥ 18 years of age
- ≥ 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 on the AMPS ADL motor skills scale (indicate increased effort during ADL task performance)
- Communicate independently and relevantly orally and in writing (without severe cognitive deficits, aphasia, significant hearing loss or dyslexia)
- Willing and interested in attending occupational therapy interventions focused on improving ADL task performance.
- ADL process ability measures <0.00 indicating that the person is unlikely to profit from educational programs focused on using adaptational strategies
- Mental illness and/or other acute (<3 months) conditions effecting ADL task performance
- Language barriers
- Known substance abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Occupational Therapy (UOT) UOT UOT is delivered by one occupational therapist. . ADAPT program ADAPT program The ADAPT program is a structured and individualized group-based program.
- Primary Outcome Measures
Name Time Method Change in observed motor ability week 12 Assessment of Motor and Process Skills (AMPS) is a unidimensional linear measure in which higher scores are better outcome
- Secondary Outcome Measures
Name Time Method Perceived change ability to problemsolve week 12 and 26 Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables
Change in self-reported satisfaction with ability to perform activities of daily living tasks- week 12 and 26 ADL-Interview (ADL-I Satisfaction)
Change in observed motor ability week 26 Assessment of Motor and Process Skills (AMPS) is a unidimensional linear measure in which higher scores are better outcome
Perceived change in ability to perform activities of daily living tasks week 12 and 26 Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables
Perceived generel health week 12 and 26 First questions in the MOS 36-item Short Form Survey Instrument based on a scale with 5 categorical variables
Change in self-reported ability to perform activities of daily living tasks week 12 and 26 ADL-Interview (ADL-I, Performance) is a unidimensional linear measure in which higher scores are better outcome
Perceived change in occupational balance week 12 and 26 Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables
Perceived change in need for assistance week 12 and 26 Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables
Perceived change in Quality fo life week 12 and 26 Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables
Perceived Quality of life week 12 and 26 EuroQoL 5 dimensions (EQ-5D) based on a scale of five categorical variables
Change in observed process ability week 12 and 26 Assessment of Motor and Process Skills (AMPS) is a unidimensional linear measure in which higher scores are better outcome
Trial Locations
- Locations (1)
The Parker Research Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Frederiksberg, Denmark
🇩🇰Frederiksberg, Denmark