Chronic ConditionGo:OTNCT05775653
Group-based [ADAPT] Versus One-to-one [Usual] Occupational Therapy: A Pilot and Feasibility Study
A study testing ADAPT program and UOT in people with Chronic Condition and Chronic Conditions, Multiple, run by Parker Research Institute at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Condition, Chronic Conditions, Multiple
- What is being tested?
- ADAPT program and UOT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Mar 2023to 9 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Parker Research Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Frederiksberg, Denmark
Frederiksberg, 2000
About this study
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)
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,
Read the 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)?
- Conditions
- Chronic Condition, Chronic Conditions, Multiple
- Being tested
- ADAPT program, UOT
- Medical subject headings
- Chronic Disease, Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADAPT programOther
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.
UOTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ADAPT program | Experimental | The ADAPT program is a structured and individualized group-based program. Receives: Other: ADAPT program |
| Usual Occupational Therapy (UOT) | Active comparator | UOT is delivered by one occupational therapist. . Receives: Other: UOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in observed motor ability
Assessment of Motor and Process Skills (AMPS) is a unidimensional linear measure in which higher scores are better outcome
Measured: week 12
Secondary outcomes (11)
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
Measured: 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
Measured: 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
Measured: week 12 and 26
Change in self-reported satisfaction with ability to perform activities of daily living tasks-
ADL-Interview (ADL-I Satisfaction)
Measured: 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
Measured: week 12 and 26
Perceived change in occupational balance
Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables
Measured: week 12 and 26
Perceived change ability to problemsolve
Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables
Measured: week 12 and 26
Perceived change in need for assistance
Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables
Measured: week 12 and 26
Perceived change in Quality fo life
Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables
Measured: week 12 and 26
Perceived Quality of life
EuroQoL 5 dimensions (EQ-5D) based on a scale of five categorical variables
Measured: 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
Measured: week 12 and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start27 Mar 2023
- Primary completion31 Jul 2023
- Study completion9 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled pilot and feasibility study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parker Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Rehabilitation Center Rødovre Municipality (Genoptræning Rødovre Kommune), Den Kommunale Kvalitetsudviklingspulje, Lundbeckpuljen, Oak Foundation, Region Hovedstadens Apotek
- Responsible party
- Principal investigator, Eva Ejlersen Wæhrens, Parker Research Institute
- Investigators
- Cecilie von Bülow, PhD, Principal investigator, Parker Institute, Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775653
- Sponsor's protocol ID
- Parker Institute
- Acronym
- Go:OT
- Status last verified
- Nov 2023
- First submitted
- 23 Feb 2023
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
von Bulow C, Bojesen SB, Hagelskjaer V, Nielsen KT, Waehrens EE. Group-based versus one-to-one occupational therapy to improve ADL ability in people with chronic conditions: a pilot and feasibility RCT of the Go:OT study. Pilot Feasibility Stud. 2026 Jun 6. doi: 10.1186/s40814-026-01855-1. Online ahead of print.
PubMed 42249425
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05775653
- Acronym / sponsor ID
- Go:OT / Parker Institute
- Conditions
- Chronic Condition, Chronic Conditions, Multiple
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Parker Research InstituteUniversity, hospital or other
- Collaborators
- Rehabilitation Center Rødovre Municipality (Genoptræning Rødovre Kommune), Den Kommunale Kvalitetsudviklingspulje, Lundbeckpuljen, Oak Foundation, Region Hovedstadens Apotek
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 9 Nov 2023 (actual)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)?
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled pilot and feasibility study
| Arm | Type | Receives |
|---|---|---|
| ADAPT program | Experimental | Other: ADAPT programThe ADAPT program is a structured and individualized group-based program. |
| Usual Occupational Therapy (UOT) | Active comparator | Other: UOTUOT is delivered by one occupational therapist. . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADAPT programThe 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. | Other | ADAPT program |
| UOTUOT 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. | Other | Usual Occupational Therapy (UOT) |
Primary outcome
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
11 secondary outcomes
Change in self-reported ability to perform activities of daily living tasks
Time frame: week 12 and 26
Change in observed motor ability
Time frame: week 26
Change in observed process ability
Time frame: week 12 and 26
Change in self-reported satisfaction with ability to perform activities of daily living tasks-
Time frame: week 12 and 26
Perceived change in ability to perform activities of daily living tasks
Time frame: week 12 and 26
Perceived change in occupational balance
Time frame: week 12 and 26
Perceived change ability to problemsolve
Time frame: week 12 and 26
Perceived change in need for assistance
Time frame: week 12 and 26
Perceived change in Quality fo life
Time frame: week 12 and 26
Perceived Quality of life
Time frame: week 12 and 26
Perceived generel health
Time frame: week 12 and 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Derived from this study: PubMed 42249425von Bulow C, Bojesen SB, Hagelskjaer V, Nielsen KT, Waehrens EE. Group-based versus one-to-one occupational therapy to improve ADL ability in people with chronic conditions: a pilot and feasibility RCT of the Go:OT study. Pilot Feasibility Stud. 2026 Jun 6. doi: 10.1186/s40814-026-01855-1. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecilie von Bülow, PhD principal investigator
Parker Institute, Bispebjerg and Frederiksberg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADAPT program and UOT in people with Chronic Condition and Chronic Conditions, Multiple, run by Parker Research Institute at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in observed motor ability (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05775653, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.