Clinical trial NCT05775653: Group-based [ADAPT] Versus One-to-one [Usual] Occupational Therapy: A Pilot and Feasibility Study
Official title: Group-based [ADAPT] Versus One-to-one [Usual] Occupational Therapy for Improving Activities of Daily Living in People With Chronic Conditions: A Protocol for a Randomized Controlled Pilot and Feasibility Study (The Go:OT Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Condition
Chronic Conditions, Multiple
Lead sponsor: Parker Research Institute
Sponsor class: OTHER
Collaborators: name: Rehabilitation Center Rødovre Municipality (Genoptræning Rødovre Kommune)
name: Den Kommunale Kvalitetsudviklingspulje
name: Lundbeckpuljen
name: Oak Foundation
name: Tværspuljen
First posted: 2023-03-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled pilot and feasibility study
Primary purpose: OTHER

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)?

Eligibility criteria: Inclusion Criteria:

* ≥ 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in observed motor ability
timeFrame: week 12
Secondary outcomes:
measure: Change in self-reported ability to perform activities of daily living tasks
timeFrame: week 12 and 26
measure: Change in observed motor ability
timeFrame: week 26
measure: Change in observed process ability
timeFrame: week 12 and 26
measure: Change in self-reported satisfaction with ability to perform activities of daily living tasks-
timeFrame: week 12 and 26
measure: Perceived change in ability to perform activities of daily living tasks
timeFrame: week 12 and 26
measure: Perceived change in occupational balance
timeFrame: week 12 and 26
measure: Perceived change ability to problemsolve
timeFrame: week 12 and 26
measure: Perceived change in need for assistance
timeFrame: week 12 and 26
measure: Perceived change in Quality fo life
timeFrame: week 12 and 26
measure: Perceived Quality of life
timeFrame: week 12 and 26
measure: Perceived generel health
timeFrame: week 12 and 26
Other outcomes:
measure: Perceived mental well-being
timeFrame: week 12 and 24
Locations:
city: Frederiksberg
country: Denmark
facility: The Parker Research Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Frederiksberg, Denmark
Study officials:
affiliation: Parker Institute, Bispebjerg and Frederiksberg Hospital
name: Cecilie von Bülow, PhD
role: PRINCIPAL_INVESTIGATOR
References: