Group-based [ADAPT] Versus One-to-one [Usual] Occupational Therapy (Go:OT Trial)

Parker Research Institute

Status: Enrolling

Conditions: Chronic Disease; Chronic Condition; Chronic Conditions, Multiple

Treatments: Behavioral: The ADAPT Program; Behavioral: UOT

Study type: Interventional

Funder types: Other

Identifiers

NCT06058754

Parker Institute,

Details and patient eligibility

About

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).

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups

ADAPT Program

Experimental group

Description:

The ADAPT Program is a structured and individualized group-based program

Treatment:

Behavioral: The ADAPT Program

Usual Occupational Therapy (UOT)

Active Comparator group

Description:

UOT is delivered by one occupational therapist in the clients homes or local environments. .

Treatment:

Behavioral: UOT