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

Chronic Disease Clinical Trial

— Go:OT  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06058754
• Other study ID #: Parker Institute,
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2023
• Est. completion date: December 6, 2024

Study information

• Verified date: September 2023
• Source: Parker Research Institute
• Contact: Cecilie von Bülow, PhD
• Phone: 38164147
• Email: Cecilie.von.bulow[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 6, 2024
• Est. primary completion date: September 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• = 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.

Exclusion criteria:

• 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.

Related Conditions & MeSH terms

• Chronic Conditions, Multiple
• Chronic Disease
• Disease
• Multiple Chronic Conditions

Intervention

Behavioral:
• The ADAPT Program
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
• UOT
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

Locations

Country	Name	City	State
Denmark	The Parker Research Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Frederiksberg, Denmark	Frederiksberg

Sponsors (6)

Lead Sponsor	Collaborator
Parker Research Institute	Den Kommunale Kvalitetsudviklingspulje, Lundbeckpuljen, Oak Foundation, Rehabilitation Center Rødovre Municipality (Genoptræning Rødovre Kommune), Tværspuljen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perceived change in ADL task performance, TRANS-Questionnaire	Participants are asked about their experienced change in a) performance of ADL tasks and b) satisfaction witt their ADL ability following occupational therapy intervention. Response options are scored on a 7-point likert scale from 'markedly worse' to 'markedly better'	week 12
Other	Perceived change in ADL task performance, TRANS-Questionnaire	Participants are asked about their experienced change in a) performance of ADL tasks and b) satisfaction witt their ADL ability following occupational therapy intervention. Response options are scored on a 7-point likert scale from 'markedly worse' to 'markedly better'	week 26
Other	Perceived change in problem-solving skills, TRANS-Questionnaire	Participants are asked about their experienced change in a) identifying daily task performance problems and b) the ability to solve task performance problems following occupational therapy intervention. Response options are scored on a 7-point likert scale from 'markedly worsened' to 'markedly better'	week 12
Other	Perceived change in problem-solving skills, TRANS-Questionnaire	Participants are asked about their experienced change in a) identifying daily task performance problems and b) the ability to solve task performance problems following occupational therapy intervention. Response options are scored on a 7-point likert scale from 'markedly worsened' to 'markedly better'	week 26
Other	Perceived change in Quality of Life, TRANS-Questionnaire	Participants are asked about their experienced change in a) overall functioning, b) mental well-being, c) physical well-being and d) social well-being following occupational therapy intervention. Response options are scored on a 7-point likert scale from 'markedly bigger' to 'markedly less'	week 12
Other	Perceived change in Quality of Life, TRANS-Questionnaire	Participants are asked about their experienced change in a) overall functioning, b) mental well-being, c) physical well-being and d) social well-being following occupational therapy intervention. Response options are scored on a 7-point likert scale from 'markedly bigger' to 'markedly less'	week 26
Other	Perceived change in global health, TRANS-Questionnaire	Participants are asked about their experienced change in global health following occupational therapy intervention. Response options are scored on a 7-point likert scale from 'markedly worse' to 'markedly better'	week 12
Other	Perceived change in global health, TRANS-Questionnaire	Participants are asked about their experienced change in global health following occupational therapy intervention. Response options are scored on a 7-point likert scale from 'markedly worse' to 'markedly better'	week 26
Other	Perceived change in assistance needed, TRANS-Questionnaire	Participants are asked about their experienced change in needing assistance in a) findings ways to ease task performance, b) accepting my chronic condition, c) managing symptoms following occupational therapy intervention. Response options are scored on a 7-point likert scale from 'markedly bigger' to 'markedly less'	week 12
Other	Perceived change in assistance needed, TRANS-Questionnaire	Participants are asked about their experienced change in needing assistance in a) findings ways to ease task performance, b) accepting my chronic condition, c) managing symptoms following occupational therapy intervention. Response options are scored on a 7-point likert scale from 'markedly bigger' to 'markedly less' less	week 26
Other	Overall experience of the occupational therapy intervention	Participants are asked to rate their experience on a 5 point Likert scale ranging from "excellent' to 'very poor'	week 12
Primary	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	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	week 26
Secondary	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	week 12
Secondary	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	week 26
Secondary	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	week 12
Secondary	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	week 26
Secondary	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	week 12
Secondary	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	week 26
Secondary	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	week 12
Secondary	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	week 26
Secondary	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	week 12
Secondary	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	week 26