Group-based [ADAPT] Versus One-to-one [Usual] Occupational Therapy: A Pilot and Feasibility Study — Go:OT  

Chronic Conditions, Multiple Clinical Trial

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)

Status Completed

Clinical Trial 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,

Clinical Trial 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)? ;

Related Conditions & MeSH terms

• Chronic Conditions, Multiple
• Chronic Disease
• Disease
• Multiple Chronic Conditions

• NCT number: NCT05775653
• Study type: Interventional
• Source: Parker Research Institute
• Status: Completed
• Phase: N/A
• Start date: March 27, 2023
• Completion date: November 9, 2023