Chronic ConditionGo:OTNCT06058754
Group-based [ADAPT] Versus One-to-one [Usual] Occupational Therapy (Go:OT Trial)
A study testing The ADAPT Program and UOT in people with Chronic Condition and Chronic Disease, run by Parker Research Institute at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Condition, Chronic Disease, Chronic Conditions, Multiple
- What is being tested?
- The ADAPT Program and UOT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Sep 2023to 6 Dec 2024
- 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
- ≥ 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.
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.
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
The Parker Research Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Frederiksberg, Denmark
Frederiksberg, 2000
Cecilie von Bülow, 38164147, Cecilie.von.bulow@regionh.dk
Eva Wæhrens, 38 16 41 66, eva.elisabet.waehrens@regionh.dk
About this study
Official title: Evaluating Group-based (ADAPT) Versus One-to-one (Usual) Occupational Therapy on Ability to Perform Activities of Daily Living (ADL) in People With Chronic Conditions (Go:OT Trial)
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).
Read the detailed description
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, e.g. by adapting and adjusting daily routines and physical environments. Municipality occupational therapy (OT) interventions are usually delivered as one-to-one sessions in the client´s home. While this intervention format might be effective in improving ADL ability, a group-based intervention format might be as effective but more cost-effective and hold other secondary gains. Guided by the British Medical Research Council's guidance (MRC) on how to develop and evaluate complex interventions, the ADAPT Program, a peer-exchange group-based program, was developed, piloted, and evaluated for its functioning and feasibility in municipality settings. These studies provided initial evidence for the ADAPT Programs effectiveness in improving ADL ability and suggests gains as improved well-being. Hence, the current phase concerns a full-scale evaluation of the ADAPT Program including evaluation of effectiveness, processes and cost-effectiveness.
Material and Methods: The randomized controlled trial (RCT), initiated with an external pilot (n=12), will include 130 home dwelling persons with decreased ADL ability following chronic conditions. Participants are randomized to either ADAPT Program (experimental) or usual OT (control).
Primary outcome: Observed ADL motor ability measured with the Assessment of Motor and Process Skills (AMPS).
Secondary outcomes: Observed ADL process ability measured with the AMPS; patient reported ADL task Performance and Satisfaction measured with the ADL-Interview (ADL-I, Performance and Satisfaction scores); Well-being assessed with the World Health Organisation-Five Well Being Index (WHO-5); Health-related Quality of Life assessed with the European Quality of Life - 5 Dimensions (EQ-5D).
Exploratory outcomes include patient reported changes, using transition scales to evaluate participants´ experience of a) changed ADL task performance and satisfaction, b) changed problem-solving skills, c) changed quality of life, d) changed global health, e) changed needs for assistance. Finally, participants are to rate their overall experience of the allocated occupational therapy intervention.
Data collection: Effectiveness and cost-effectiveness data are collected at baseline and post intervention i.e., 3-months (week 12) and 6-months (week 26) from baseline. Costs will be estimated based on micro costing and national registries. Effects will be Quality Adjusted Life Years and changes in AMPS ADL motor ability. Process evaluation data will be collected using registration forms and semi-structured qualitative interviews.
- Being tested
- The ADAPT Program, UOT
- Keywords
- Occupational therapy, ADL, Adaptation, Chronic condition, Peer-exchange, group-based
- 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.
The ADAPT ProgramBehavioural
Also called Adaptation, Compensatory, occupational therapy, group-based
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
UOTBehavioural
Also called Usual occupational therapy
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
| Study group | Role | What they receive |
|---|---|---|
| ADAPT Program | Experimental | The ADAPT Program is a structured and individualized group-based program Receives: Behavioral: The ADAPT Program |
| Usual Occupational Therapy (UOT) | Active comparator | UOT is delivered by one occupational therapist in the clients homes or local environments. . Receives: Behavioral: UOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 12
Secondary outcomes (11)
Change in observed ADL motor ability, using 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
Measured: week 26
Change in observed ADL process ability, using AMPS
Observation-based ADL process ability (reflecting efficiency, safety and independence). Linear measures of ADL process ability generated using Rasch measurement models. Higher scores mean better ADL ability
Measured: week 12
Change in observed ADL process ability, using AMPS
Observation-based ADL process ability (reflecting efficiency, safety and independence). Linear measures of ADL process ability generated using Rasch measurement models. Higher scores mean better ADL ability
Measured: week 26
Change in self-reported ADL ability, using the ADL-Interview (ADL-I), Performance scale
Self-reported ability to perform ADL tasks, based on interview. Linear measures of ADL ability generated using Rasch measurement models. Higher scores mean better ADL ability
Measured: week 12
Change in self-reported ADL ability with ADL-I, Performance scale
Self-reported ability ot perform ADL tasks, based on interview. Linear measures of ADL ability generated using Rasch measurement models. Higher scores mean better ADL ability
Measured: week 26
Change in self-reported satisfaction with ADL ability, using ADL-I, Satisfaction scale
Self-reported satisfaction with ADL task performance, based on interview. Linear measures of ADL ability generated using Rasch measurement models. Higher scores means higher satisfaction
Measured: week 12
Change in self-reported satisfaction with ADL ability, using the ADL-Interview (ADL-I), Satisfaction scale
Self-reported satisfaction with ADL task performance, based on interview. Linear measures of ADL ability will be generated using Rasch measurement models. Higher scores means higher satisfaction
Measured: week 26
Well-being, using the World Health Organisation- Five Well-Being Index (WHO-5)
Participants are asked to rate well being in regard to five questions. Response options are scored on a 6-point scale in which 0=at no time to 0=all the time. Lower scores are lower well-being
Measured: week 12
Well-being, using The World Health Organisation- Five Well-Being Index (WHO-5)
Participants are asked to rate well being in regard to five questions. Response options are scored on a 6-point scale in which 0=at no time to 0=all the time. Lower scores are lower well-being
Measured: week 26
Quality of life, using the EuroQoL 5 dimensions (EQ-5D)
Participants are asked to rate 5 aspects of health-related quality of life Quality of life in regard to five items scores on a 5 point likert scale from I am not/have none to I have extreme/i cannot
Measured: week 12
Quality of life, using EQ-5D
Participants are asked to rate 5 aspects of health-related quality of life Quality of life in regard to five items scores on a 5 point likert scale from I am not/have none to I have extreme/i cannot
Measured: week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start4 Sep 2023
- Primary completion27 Sep 2024 (estimated)
- Study completion6 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center, double-blinded, randomized, parallel-group, equivalence 6-months follow-up study with external pilot, effect, process and economic evaluations
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (estimated)
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
- NCT06058754
- Sponsor's protocol ID
- Parker Institute,
- Acronym
- Go:OT
- Status last verified
- Sep 2023
- First submitted
- 15 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Group-based (ADAPT) Versus One-to-one (Usual) Occupational Therapy on Ability to Perform Activities of Daily Living (ADL) in People With Chronic Conditions (Go:OT Trial)
- ClinicalTrials.gov ID
- NCT06058754
- Acronym / sponsor ID
- Go:OT / Parker Institute,
- Keywords
- Occupational therapy, ADL, Adaptation, Chronic condition, Peer-exchange, group-based
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- 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
- 4 Sep 2023 (actual)
- Primary completion
- 27 Sep 2024 (estimated)
- Study completion
- 6 Dec 2024 (estimated)
- First posted
- 28 Sep 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.
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).
Detailed description
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, e.g. by adapting and adjusting daily routines and physical environments. Municipality occupational therapy (OT) interventions are usually delivered as one-to-one sessions in the client´s home. While this intervention format might be effective in improving ADL ability, a group-based intervention format might be as effective but more cost-effective and hold other secondary gains. Guided by the British Medical Research Council's guidance (MRC) on how to develop and evaluate complex interventions, the ADAPT Program, a peer-exchange group-based program, was developed, piloted, and evaluated for its functioning and feasibility in municipality settings. These studies provided initial evidence for the ADAPT Programs effectiveness in improving ADL ability and suggests gains as improved well-being. Hence, the current phase concerns a full-scale evaluation of the ADAPT Program including evaluation of effectiveness, processes and cost-effectiveness.
Material and Methods: The randomized controlled trial (RCT), initiated with an external pilot (n=12), will include 130 home dwelling persons with decreased ADL ability following chronic conditions. Participants are randomized to either ADAPT Program (experimental) or usual OT (control).
Primary outcome: Observed ADL motor ability measured with the Assessment of Motor and Process Skills (AMPS).
Secondary outcomes: Observed ADL process ability measured with the AMPS; patient reported ADL task Performance and Satisfaction measured with the ADL-Interview (ADL-I, Performance and Satisfaction scores); Well-being assessed with the World Health Organisation-Five Well Being Index (WHO-5); Health-related Quality of Life assessed with the European Quality of Life - 5 Dimensions (EQ-5D).
Exploratory outcomes include patient reported changes, using transition scales to evaluate participants´ experience of a) changed ADL task performance and satisfaction, b) changed problem-solving skills, c) changed quality of life, d) changed global health, e) changed needs for assistance. Finally, participants are to rate their overall experience of the allocated occupational therapy intervention.
Data collection: Effectiveness and cost-effectiveness data are collected at baseline and post intervention i.e., 3-months (week 12) and 6-months (week 26) from baseline. Costs will be estimated based on micro costing and national registries. Effects will be Quality Adjusted Life Years and changes in AMPS ADL motor ability. Process evaluation data will be collected using registration forms and semi-structured qualitative interviews.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A single-center, double-blinded, randomized, parallel-group, equivalence 6-months follow-up study with external pilot, effect, process and economic evaluations
| Arm | Type | Receives |
|---|---|---|
| ADAPT Program | Experimental | Behavioral: The ADAPT ProgramThe ADAPT Program is a structured and individualized group-based program |
| Usual Occupational Therapy (UOT) | Active comparator | Behavioral: UOTUOT is delivered by one occupational therapist in the clients homes or local environments. . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| The ADAPT ProgramAlso: Adaptation, Compensatory, occupational therapy, group-basedThe 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 | Behavioural | ADAPT Program |
| UOTAlso: Usual occupational therapyUOT 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 | Behavioural | Usual Occupational Therapy (UOT) |
Primary outcome
Change in observed ADL motor ability, Assessment of Motor and Process Skills (AMPS)
Time frame: week 12
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
11 secondary outcomes
Change in observed ADL motor ability, using AMPS
Time frame: week 26
Change in observed ADL process ability, using AMPS
Time frame: week 12
Change in observed ADL process ability, using AMPS
Time frame: week 26
Change in self-reported ADL ability, using the ADL-Interview (ADL-I), Performance scale
Time frame: week 12
Change in self-reported ADL ability with ADL-I, Performance scale
Time frame: week 26
Change in self-reported satisfaction with ADL ability, using ADL-I, Satisfaction scale
Time frame: week 12
Change in self-reported satisfaction with ADL ability, using the ADL-Interview (ADL-I), Satisfaction scale
Time frame: week 26
Well-being, using the World Health Organisation- Five Well-Being Index (WHO-5)
Time frame: week 12
Well-being, using The World Health Organisation- Five Well-Being Index (WHO-5)
Time frame: week 26
Quality of life, using the EuroQoL 5 dimensions (EQ-5D)
Time frame: week 12
Quality of life, using EQ-5D
Time frame: week 26
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
Related trials for Chronic Condition
RecruitingPhase 1
Phase 1 Study of 6MW5311 in Adults With Relapsed or Refractory Blood Cancers
AML, Multiple Myeloma
RecruitingPhase 2/3
Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Not yet recruitingPhase 4
Propofol Target-Controlled Infusion Versus Dexmedetomidine for Sedation During Chronic Subdural Hematoma Surgery Under Local Anesthesia
Chronic Subdural Hematoma
Not yet recruiting
Foot Drop Rehabilitation and Mobility in Chronic Stroke
Stroke
Not yet recruiting
Comparative Feasibility and Effectiveness of Medically Tailored Meals Approaches for Pediatric End-Stage Kidney Disease
End Stage Kidney Disease (ESKD)
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 The ADAPT Program and UOT in people with Chronic Condition and Chronic Disease, 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cecilie von Bülow, PhD (38164147, Cecilie.von.bulow@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in observed ADL motor ability, Assessment of Motor and Process Skills (AMPS) (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2023.