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

Primary Purpose

Chronic Condition, Chronic Conditions, Multiple

Status
Not yet recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
ADAPT program
UOT
Sponsored by
Parker Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Condition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ADAPT program

Usual Occupational Therapy (UOT)

Arm Description

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

UOT is delivered by one occupational therapist. .

Outcomes

Primary Outcome Measures

Change in observed motor ability
Assessment of Motor and Process Skills (AMPS) is a unidimensional linear measure in which higher scores are better outcome

Secondary Outcome Measures

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

Full Information

First Posted
February 23, 2023
Last Updated
March 7, 2023
Sponsor
Parker Research Institute
Collaborators
Rehabilitation Center Rødovre Municipality (Genoptræning Rødovre Kommune), Den Kommunale Kvalitetsudviklingspulje, Lundbeckpuljen, Oak Foundation, Tværspuljen
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1. Study Identification

Unique Protocol Identification Number
NCT05775653
Brief Title
Group-based [ADAPT] Versus One-to-one [Usual] Occupational Therapy
Acronym
Go:OT
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parker Research Institute
Collaborators
Rehabilitation Center Rødovre Municipality (Genoptræning Rødovre Kommune), Den Kommunale Kvalitetsudviklingspulje, Lundbeckpuljen, Oak Foundation, Tværspuljen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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,
Detailed Description
TThe specific aims of this pilot and feasibility study are to evaluate: how recruitment procedures work and if participants accept randomization (recruitment and retention) if clients feel adequately informed about the purpose of the assessments done and the content and time use regarding interventions delivered (trial participation) if trial participation has unanticipated impacts on ADAPT OTs (e.g. workload) (Impact of trial on staff) if registration forms and outcome measurements are completed (Completion rates) the extent of which the ADAPT OT adhere to the ADAPT program manual and deliver key components within each session (fidelity and dose) if data informing about intervention delivered in UOT is accessible from client records (Assessable information) if ADAPT OTs perceive organizational factors to facilitate or hinder program delivery (adaptation of trial conduct to local context)?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Condition, Chronic Conditions, Multiple

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled pilot and feasibility study
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ADAPT program
Arm Type
Experimental
Arm Description
The ADAPT program is a structured and individualized group-based program.
Arm Title
Usual Occupational Therapy (UOT)
Arm Type
Active Comparator
Arm Description
UOT is delivered by one occupational therapist. .
Intervention Type
Other
Intervention Name(s)
ADAPT program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
UOT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in observed motor ability
Description
Assessment of Motor and Process Skills (AMPS) is a unidimensional linear measure in which higher scores are better outcome
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Change in self-reported ability to perform activities of daily living tasks
Description
ADL-Interview (ADL-I, Performance) is a unidimensional linear measure in which higher scores are better outcome
Time Frame
week 12 and 26
Title
Change in observed motor ability
Description
Assessment of Motor and Process Skills (AMPS) is a unidimensional linear measure in which higher scores are better outcome
Time Frame
week 26
Title
Change in observed process ability
Description
Assessment of Motor and Process Skills (AMPS) is a unidimensional linear measure in which higher scores are better outcome
Time Frame
week 12 and 26
Title
Change in self-reported satisfaction with ability to perform activities of daily living tasks-
Description
ADL-Interview (ADL-I Satisfaction)
Time Frame
week 12 and 26
Title
Perceived change in ability to perform activities of daily living tasks
Description
Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables
Time Frame
week 12 and 26
Title
Perceived change in occupational balance
Description
Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables
Time Frame
week 12 and 26
Title
Perceived change ability to problemsolve
Description
Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables
Time Frame
week 12 and 26
Title
Perceived change in need for assistance
Description
Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables
Time Frame
week 12 and 26
Title
Perceived change in Quality fo life
Description
Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables
Time Frame
week 12 and 26
Title
Perceived Quality of life
Description
EuroQoL 5 dimensions (EQ-5D) based on a scale of five categorical variables
Time Frame
week 12 and 26
Title
Perceived generel health
Description
First questions in the MOS 36-item Short Form Survey Instrument based on a scale with 5 categorical variables
Time Frame
week 12 and 26
Other Pre-specified Outcome Measures:
Title
Perceived mental well-being
Description
WHO-5 questionnaire based on a 6-point ordinal scale in which higher is better outcome
Time Frame
week 12 and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cecilie von Bülow, PhD
Phone
38164163
Email
Cecilie.von.bulow@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Wæhrens, Professor
Phone
38164166
Email
eva.elisabet.waehrens@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecilie von Bülow, PhD
Organizational Affiliation
Parker Institute, Bispebjerg and Frederiksberg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Parker Research Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Frederiksberg, Denmark
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecilie von Bülow
Phone
38164163
Email
Cecilie.von.bulow@regionh.dk
First Name & Middle Initial & Last Name & Degree
Eva Wæhrens
Phone
38 16 41 66
Email
eva.elisabet.waehrens@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Group-based [ADAPT] Versus One-to-one [Usual] Occupational Therapy

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