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

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)

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,

Study Overview

• Status: Completed
• Conditions: Chronic Conditions, Multiple; Chronic Condition
• Intervention / Treatment: Other: ADAPT program; Other: UOT

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)?

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg, Denmark, 2000
    • The Parker Research Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Frederiksberg, Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADAPT program; The ADAPT program is a structured and individualized group-based program.	Other: ADAPT program; The ADAPT program is a structured and individualized group-based program, in which two occupational therapists teach groups of people the skills of problem-solving more efficiently as means to overcome ADL task performance problems. The ADAPT program 3.0 includes 10 two-hour sessions and is followed by two booster sessions to support sustainable gains.
Active Comparator: Usual Occupational Therapy (UOT); UOT is delivered by one occupational therapist. .	Other: UOT; UOT is delivered by one occupational therapist. Sessions are individualised and focus on improving ADL ability e.g. by practicing the performance of ADL task. UOT typiccally includes 7 one-to-one sessions of 60 minutes, delivered over a 10-week period in the clients´ homes. The dose is however not fixed but based on the occupational therapists´ clinical judgement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in observed motor ability	Assessment of Motor and Process Skills (AMPS) is a unidimensional linear measure in which higher scores are better outcome	week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-reported ability to perform activities of daily living tasks	ADL-Interview (ADL-I, Performance) is a unidimensional linear measure in which higher scores are better outcome	week 12 and 26
Change in observed motor ability	Assessment of Motor and Process Skills (AMPS) is a unidimensional linear measure in which higher scores are better outcome	week 26
Change in observed process ability	Assessment of Motor and Process Skills (AMPS) is a unidimensional linear measure in which higher scores are better outcome	week 12 and 26
Change in self-reported satisfaction with ability to perform activities of daily living tasks-	ADL-Interview (ADL-I Satisfaction)	week 12 and 26
Perceived change in ability to perform activities of daily living tasks	Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables	week 12 and 26
Perceived change in occupational balance	Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables	week 12 and 26
Perceived change ability to problemsolve	Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables	week 12 and 26
Perceived change in need for assistance	Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables	week 12 and 26
Perceived change in Quality fo life	Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables	week 12 and 26
Perceived Quality of life	EuroQoL 5 dimensions (EQ-5D) based on a scale of five categorical variables	week 12 and 26
Perceived generel health	First questions in the MOS 36-item Short Form Survey Instrument based on a scale with 5 categorical variables	week 12 and 26

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived mental well-being	WHO-5 questionnaire based on a 6-point ordinal scale in which higher is better outcome	week 12 and 24

Collaborators and Investigators

• Sponsor: Parker Research Institute
• Collaborators: Oak Foundation; Rehabilitation Center Rødovre Municipality (Genoptræning Rødovre Kommune); Den Kommunale Kvalitetsudviklingspulje; Lundbeckpuljen; Tværspuljen
• Investigators: Principal Investigator: Cecilie von Bülow, PhD, Parker Institute, Bispebjerg and Frederiksberg Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): November 9, 2023

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease; Chronic Disease; Multiple Chronic Conditions
• Other Study ID Numbers: Parker Institute

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No