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Completed

NCT Number: NCT05775653

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

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,

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Key information

Conditions

Chronic Condition Chronic Conditions, Multiple Chronic Disease Disease Attributes Multiple Chronic Conditions Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Frederiksberg, 2000, Denmark

About this study

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)?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in observed motor ability

    Time frame: week 12

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

Secondary outcomes

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

    Time frame: week 12 and 26

    ADL-Interview (ADL-I, Performance) is a unidimensional linear measure in which higher scores are better outcome

  2. Change in observed motor ability

    Time frame: week 26

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

  3. Change in observed process ability

    Time frame: week 12 and 26

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

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

    Time frame: week 12 and 26

    ADL-Interview (ADL-I Satisfaction)

  5. Perceived change in ability to perform activities of daily living tasks

    Time frame: week 12 and 26

    Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables

  6. Perceived change in occupational balance

    Time frame: week 12 and 26

    Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables

  7. Perceived change ability to problemsolve

    Time frame: week 12 and 26

    Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables

  8. Perceived change in need for assistance

    Time frame: week 12 and 26

    Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables

  9. Perceived change in Quality fo life

    Time frame: week 12 and 26

    Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables

  10. Perceived Quality of life

    Time frame: week 12 and 26

    EuroQoL 5 dimensions (EQ-5D) based on a scale of five categorical variables

  11. Perceived generel health

    Time frame: week 12 and 26

    First questions in the MOS 36-item Short Form Survey Instrument based on a scale with 5 categorical variables

Other outcomes

  1. Perceived mental well-being

    Time frame: week 12 and 24

    WHO-5 questionnaire based on a 6-point ordinal scale in which higher is better outcome

Sponsors and collaborators

Lead sponsor

Parker Research Institute

Other

Collaborators

  • Den Kommunale Kvalitetsudviklingspulje
  • Lundbeckpuljen
  • Oak Foundation
  • Rehabilitation Center Rødovre Municipality (Genoptræning Rødovre Kommune)
  • Tværspuljen

Registry information

Official study 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)

Acronym: Go:OT

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 20, 2023
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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