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

NCT05775653 | Completed

• 1 other identifier: Parker Institute
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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,

Conditions

Chronic Condition; Chronic Conditions, Multiple

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in self-reported ability to perform activities of daily living tasks

  week 12 and 26

• Change in observed motor ability

  week 26

• Change in observed process ability

  week 12 and 26

• Change in self-reported satisfaction with ability to perform activities of daily living tasks-

  week 12 and 26

• Perceived change in ability to perform activities of daily living tasks

  week 12 and 26

Other Outcomes (1)

• Perceived mental well-being

  week 12 and 24

Study Arms (2)

ADAPT program

EXPERIMENTAL

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

Other: ADAPT program

Usual Occupational Therapy (UOT)

ACTIVE COMPARATOR

UOT is delivered by one occupational therapist. .

Other: UOT

Interventions

ADAPT program OTHER

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.

ADAPT program

UOT OTHER

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.

Usual Occupational Therapy (UOT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Parker Research Institute: lead
• Rehabilitation Center Rødovre Municipality (Genoptræning Rødovre Kommune): collaborator
• Den Kommunale Kvalitetsudviklingspulje: collaborator
• Lundbeckpuljen: collaborator
• Oak Foundation: collaborator
• Tværspuljen: collaborator

Study Sites (1)

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

Frederiksberg, 2000, Denmark

Location

MeSH Terms

Conditions

Chronic Disease; Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cecilie von Bülow, PhD

  Parker Institute, Bispebjerg and Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The trial attempts to blind clients and assessors. Clients are informed that they will be allocated to one of two occupational therapy intervention programs that both aims to improve ADL ability, but overall primarily differ in the format i.e. a group-based versus a one-to-one intervention program. Clients are however not informed, which of the two types of formats that are the new experimental intervention format (ADAPT). Baseline assessments are conducted prior to randomization by the local project coordinator and the project coordinator is instructed not to reveal which intervention that is the new experimental intervention. The post- and follow-up assessor, an externally recruited occupationa therapist from a nearby hospital research unit, is also instructed not to disclose which intervention that is the new. Finally, all clients are reminded not to disclose any details, that may provide the outcome assessor with insight regarding their group allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A randomized controlled pilot and feasibility study

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 20, 2023
• Study Start: March 27, 2023
• Primary Completion: July 31, 2023
• Study Completion: November 9, 2023
• Last Updated: May 6, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)