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

NCT06058754 | Unknown

• 1 other identifier: Parker Institute,
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Condition; Chronic Disease; Chronic Conditions, Multiple

Keywords

Occupational therapy; ADL; Adaptation; Chronic condition; Peer-exchange; group-based

Outcome Measures

Primary Outcomes (1)

• Change in observed ADL motor ability, Assessment of Motor and Process Skills (AMPS)

  Observation-based ADL motor ability (reflecting physical effort and independence ). Linear measures of ADL motor ability generated using Rasch measurement models. Higher scores mean better ADL ability

  week 12

Secondary Outcomes (11)

• Change in observed ADL motor ability, using AMPS

  week 26

• Change in observed ADL process ability, using AMPS

  week 12

• Change in observed ADL process ability, using AMPS

  week 26

• Change in self-reported ADL ability, using the ADL-Interview (ADL-I), Performance scale

  week 12

• Change in self-reported ADL ability with ADL-I, Performance scale

  week 26

Other Outcomes (11)

• Perceived change in ADL task performance, TRANS-Questionnaire

  week 12

• Perceived change in ADL task performance, TRANS-Questionnaire

  week 26

• Perceived change in problem-solving skills, TRANS-Questionnaire

  week 12

Study Arms (2)

ADAPT Program

EXPERIMENTAL

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

Behavioral: The ADAPT Program

Usual Occupational Therapy (UOT)

ACTIVE COMPARATOR

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

Behavioral: UOT

Interventions

The ADAPT Program BEHAVIORAL

The ADAPT Program is a structured and individualized 10-week 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 2 individual two-hour sessions (sessions 1 and 10) conducted in the clients homes and eight two-hour group-based sessions (sessions 2-9). Moreover, two booster sessions (sessions 11 and 12) are delivered to support sustainable gains after termination of the 10-week ADAPT Program 3.0

Also known as: Adaptation, Compensatory, occupational therapy, group-based, peer-exchange, problem-solving

ADAPT Program

UOT BEHAVIORAL

UOT is delivered by one occupational therapist. Sessions are individualised and focused on improving ADL ability e.g. by practicing the performance of ADL task or adjusting home environments. UOT typically 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 in collaboration with the individual client

Also known as: Usual occupational therapy

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:

• ≥ 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.

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.
• 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.

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

RECRUITING

MeSH Terms

Conditions

Chronic Disease; Multiple Chronic Conditions

Interventions

Acclimatization; Occupational Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Adaptation, Physiological; Physiological Phenomena; Adaptation, Biological; Biological Phenomena; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Cecilie von Bülow, PhD

  Parker Institute, Bispebjerg and Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecilie von Bülow, PhD

CONTACT

38164147; Cecilie.von.bulow@regionh.dk

Eva Wæhrens, Professor

CONTACT

38164166; eva.elisabet.waehrens@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants 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 terms of their format i.e. a group-based versus a one-to-one intervention program format. Participants are not informed, which of the two types of formats that are the new experimental intervention format (ADAPT) nor control (UOT). Baseline assessments are conducted prior to randomization by a local employed occupational therapists, who is instructed not to reveal which intervention that is the new experimental intervention. The post and follow-up assessors, a research occupational therapy assistant employed at the Parker Institute, is also instructed not to disclose which intervention that is the new experimental one. Finally, all participants are reminded not to disclose any details, that may provide the outcome assessors with insights regarding their allocated study arm.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher, Associate Professor

Model Details: A single-center, double-blinded, randomized, parallel-group, equivalence 6-months follow-up study with external pilot, effect, process and economic evaluations

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 28, 2023
• Study Start: September 4, 2023
• Primary Completion: September 27, 2024
• Study Completion: December 6, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

DK (1)