Clinical trial NCT06058754: Group-based [ADAPT] Versus One-to-one [Usual] Occupational Therapy (Go:OT Trial)
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Condition
Chronic Disease
Chronic Conditions, Multiple
Keywords: Occupational therapy
ADL
Adaptation
Chronic condition
Peer-exchange
group-based
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: 2023-09-28
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-center, double-blinded, randomized, parallel-group, equivalence 6-months follow-up study with external pilot, effect, process and economic evaluations
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This trial aims to evaluate the ADAPT Program in terms of efficacy, process and cost-efficacy compared to usual occupational therapy (UOT) in people with decreased ability to perform activities of daily living (ADL) following chronic conditions. As both the ADAPT Program and UOT are targeted improvements in ADL ability, the primary objective of this trial is to assess equivalence between the ADAPT Program and UOT on changes in ADL ability as measured with the Assessment of Motor and Process Skills (AMPS).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in observed ADL motor ability, Assessment of Motor and Process Skills (AMPS)
timeFrame: week 12
Secondary outcomes:
measure: Change in observed ADL motor ability, using AMPS
timeFrame: week 26
measure: Change in observed ADL process ability, using AMPS
timeFrame: week 12
measure: Change in observed ADL process ability, using AMPS
timeFrame: week 26
measure: Change in self-reported ADL ability, using the ADL-Interview (ADL-I), Performance scale
timeFrame: week 12
measure: Change in self-reported ADL ability with ADL-I, Performance scale
timeFrame: week 26
measure: Change in self-reported satisfaction with ADL ability, using ADL-I, Satisfaction scale
timeFrame: week 12
measure: Change in self-reported satisfaction with ADL ability, using the ADL-Interview (ADL-I), Satisfaction scale
timeFrame: week 26
measure: Well-being, using the World Health Organisation- Five Well-Being Index (WHO-5)
timeFrame: week 12
measure: Well-being, using The World Health Organisation- Five Well-Being Index (WHO-5)
timeFrame: week 26
measure: Quality of life, using the EuroQoL 5 dimensions (EQ-5D)
timeFrame: week 12
measure: Quality of life, using EQ-5D
timeFrame: week 26
Other outcomes:
measure: Perceived change in ADL task performance, TRANS-Questionnaire
timeFrame: week 12
measure: Perceived change in ADL task performance, TRANS-Questionnaire
timeFrame: week 26
measure: Perceived change in problem-solving skills, TRANS-Questionnaire
timeFrame: week 12
measure: Perceived change in problem-solving skills, TRANS-Questionnaire
timeFrame: week 26
measure: Perceived change in Quality of Life, TRANS-Questionnaire
timeFrame: week 12
measure: Perceived change in Quality of Life, TRANS-Questionnaire
timeFrame: week 26
measure: Perceived change in global health, TRANS-Questionnaire
timeFrame: week 12
measure: Perceived change in global health, TRANS-Questionnaire
timeFrame: week 26
measure: Perceived change in assistance needed, TRANS-Questionnaire
timeFrame: week 12
measure: Perceived change in assistance needed, TRANS-Questionnaire
timeFrame: week 26
measure: Overall experience of the occupational therapy intervention
timeFrame: week 12
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: