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Effect of Occupational Therapy at Home E-Rehabilitation (OTHER) for Persons Post-stroke (OTHER)

Primary Purpose

Stroke, eHealth, Occupational Therapy

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
OTHER-intervention (Occupational Therapy at Home E-Rehabilitation)
Sponsored by
Amsterdam University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke

Eligibility Criteria

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

Inclusion Criteria: be able to walk a few steps with or without a walking device. 60 years or older an assessment score of at least 16 on the Montreal Cognitive Assessment (MoCA) an indication for follow up GR at home Exclusion Criteria: Who are terminally ill Who have severe aphasia; problems with understanding. Who has been assessed legally incapable by a geriatric doctor

Sites / Locations

  • TanteLouiseRecruiting
  • ZZG HerstelcentrumRecruiting
  • Cicero ZorggroepRecruiting
  • SevagramRecruiting
  • Zorgcirkel Westerhout
  • Omring locatie LindendealRecruiting
  • Vivium NaardenheemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Care as usual

OTHER-intervention

Arm Description

Care as usual, consist of GR rehabilitation when a patient is back at home.

The OTHER-intervention is part of the OT care. Start during inpatient GR rehabilitation and goes on 12 weeks afte discharge when a patient is home. The OT will coach a patient and use a activity monitoring system. Also videoconferencing will be used.

Outcomes

Primary Outcome Measures

Changes in Canadian Occupational Performance measure (COPM-p) at three time points
The primary outcome measure is 'perceived daily performance' 4 weeks, 12 weeks and 24 weeks after the start of OTHER compared to baseline functioning, measured with the Canadian Occupational Performance measure. The COPM results in a performance score (COPM-p). The COPM is a person-centred, occupation-focused outcome measure for the detection of change in perceived daily performance over time. The COPM results in a performance score (COPM-p) and a satisfaction score (COPM-s). Through a semi-structured interview, persons will prioritize up to five daily activities that deemed most important and rate each on a 10-point scale regarding perceived performance (COPM-p) (1=not able to do at all and 10 = able to do extremely well. The mean COPM-p will be obtained by summing the ratings and dividing them by the number of prioritized activities.

Secondary Outcome Measures

Changes in Canadian Occupational Performance measure (COPM-s)
Persons post-stroke satisfaction in performing daily functioning will be measured with the COPM-s(35). Next to the COPM-p, participants rated the prioritized daily activities on a 10-point scale regarding performance satisfaction (COPM-s) (1= not satisfied at all and 10= extremely satisfied).
Self-management
Self-management. The Patient-Reported Outcome Occupational Therapy (PROM-OT) is developed to measure the outcome and quality of OT in the Netherlands from a client perspective.The PROM-OT contains 13 questions regarding the outcome of OT for the person (e.g. I can perform my daily activities, whether or not with help/devices (for example self-care, household, leisure, work) and using scoring with 11 point scale (0= lowest score and 10 = highest score). It focusses on daily activities, being able to self-manage related to daily functioning and satisfaction of OT.
Patient's quality of life.
The EuroQol-5D-5L(41) will be used to measure 'health-related quality of life' outcomes (HRQOL).The HRQOL is measured on 5 health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each health dimension has 5 severity levels ranging between no problems to extreme problems. The EQ- visual analogue scale (VAS) measures the persons' self-rated health on a scale from 0 to 100 (0= worst health and 100 the best health). The participants' EQ-5D-5L health states will be converted into utility values the Dutch tariff.
Capability of older people
The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. Unlike most profile measures used in economic evaluations, the ICECAP-O focuses on wellbeing defined in a broader sense, rather than health. The measure covers attributes of wellbeing that were found to be important to older people in the United Kingdom. ICECAP-O comprises five attributes (the lay terms are in brackets): Attachment (love and friendship), Security (thinking about the future without concern), Role (doing things that make participants feel valued), Enjoyment (enjoyment and pleasure), Control (independence). Score from 1 till 4 (1 = lowest and 4 = highest score
Activity level
The wearable activity monitor (PAM) will be applied to measure the amount of active movement in minutes per day.
Mobility functioning
Time up and go test is a screening tool used to test basic mobility skills of frail elderly patients (60-90 years old) an persons with stroke.
Satisfaction with OT
The Patient-Reported Outcome Measure - Occupational Therapy (PROM-OT) is developed to measure the outcome and quality of OT in the Netherlands from a client perspective. The PROM-OT contains 13 questions regarding the outcome of OT for the person (e.g. I can perform my daily activities, whether or not with help/devices (for example self-care, household, leisure, work) and using scoring with 11 point scale (0= lowest score and 10 = highest score). It focusses on daily activities, being able to self-manage related to daily functioning and satisfaction of OT.
Societal cost
Costs will be measured from a societal perspective, meaning that all costs related to the intervention will be measured, irrespective of who pays or benefits from them. Cost will be measured using retrospective cost questionnaires administered after 12 weeks and 24 weeks.

Full Information

First Posted
March 30, 2023
Last Updated
July 20, 2023
Sponsor
Amsterdam University of Applied Sciences
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT05855226
Brief Title
Effect of Occupational Therapy at Home E-Rehabilitation (OTHER) for Persons Post-stroke
Acronym
OTHER
Official Title
Supporting Daily Functioning of Persons With a Neurological Disorder: (Cost)Effectiveness of Occupational Therapy at Home E-Rehabilitation (OTHER) for Persons Post-stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam University of Applied Sciences
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

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

5. Study Description

Brief Summary
The goal of this (cost)effectiveness study is to compare care as usual with OTHER-intervention in Cerebro Vascular Accident (CVA) older adults in Geriatric Rehabilitation (GR). The main question[s] it aims to answer are: What is the effectiveness of OTHER, as compared to occupational therapy as usual (CAU), on improving the self-perceived performance in daily activities of community-dwelling older persons post-stroke over a 24-week period after initiation of OTHER or CAU, as measured longitudinally (at week 4, 13 and 26)? Secondary: What is the effectiveness of OTHER on improving satisfaction with the perceived daily performance of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach) What is the effectiveness of OTHER on improving physical activity of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach) What is the effectiveness of OTHER on improving self-management of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach) How do persons post-stroke and OT's experience and how do they reflect on OTHER in supporting a sense of self-management, safety and improving daily functioning? (qualitative approach). What factors influenced the intervention delivery and the perceived benefits in the OTHER study (process evaluation)? 1) monitoring treatment fidelity, barriers and facilitators for implementation; 2) gain insight into the impact of OTHER on the GR transition to home; 3) to gain insight into what stroke survivors and OT's think of OTHER. 4) how participants, and professionals experience and thoughts they have on the OTHER-intervention in supporting daily functioning and self-management Cost-effectiveness What is the cost-effectiveness of OTHER on improving self-perceived performance in daily activities and Quality Adjusted Life Years (QALYs) of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach) Participants will get the OTHER-intervention treatment given by de occupational therapist which consists of activity monitoring, coaching and videoconferencing to optimalise the transition from clinical care to home. Researchers will compare care as usual to see if there is a effect on improving the self-perceived performance in daily activities, self-management and improving physical activity .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, eHealth, Occupational Therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Care as usual
Arm Type
No Intervention
Arm Description
Care as usual, consist of GR rehabilitation when a patient is back at home.
Arm Title
OTHER-intervention
Arm Type
Experimental
Arm Description
The OTHER-intervention is part of the OT care. Start during inpatient GR rehabilitation and goes on 12 weeks afte discharge when a patient is home. The OT will coach a patient and use a activity monitoring system. Also videoconferencing will be used.
Intervention Type
Other
Intervention Name(s)
OTHER-intervention (Occupational Therapy at Home E-Rehabilitation)
Intervention Description
The occupational therapist will use activity monitoring and coaching techniques with videoconference during OTHER.
Primary Outcome Measure Information:
Title
Changes in Canadian Occupational Performance measure (COPM-p) at three time points
Description
The primary outcome measure is 'perceived daily performance' 4 weeks, 12 weeks and 24 weeks after the start of OTHER compared to baseline functioning, measured with the Canadian Occupational Performance measure. The COPM results in a performance score (COPM-p). The COPM is a person-centred, occupation-focused outcome measure for the detection of change in perceived daily performance over time. The COPM results in a performance score (COPM-p) and a satisfaction score (COPM-s). Through a semi-structured interview, persons will prioritize up to five daily activities that deemed most important and rate each on a 10-point scale regarding perceived performance (COPM-p) (1=not able to do at all and 10 = able to do extremely well. The mean COPM-p will be obtained by summing the ratings and dividing them by the number of prioritized activities.
Time Frame
The investigators assess the changes across three time points (one, three and six months)
Secondary Outcome Measure Information:
Title
Changes in Canadian Occupational Performance measure (COPM-s)
Description
Persons post-stroke satisfaction in performing daily functioning will be measured with the COPM-s(35). Next to the COPM-p, participants rated the prioritized daily activities on a 10-point scale regarding performance satisfaction (COPM-s) (1= not satisfied at all and 10= extremely satisfied).
Time Frame
baseline, 4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR
Title
Self-management
Description
Self-management. The Patient-Reported Outcome Occupational Therapy (PROM-OT) is developed to measure the outcome and quality of OT in the Netherlands from a client perspective.The PROM-OT contains 13 questions regarding the outcome of OT for the person (e.g. I can perform my daily activities, whether or not with help/devices (for example self-care, household, leisure, work) and using scoring with 11 point scale (0= lowest score and 10 = highest score). It focusses on daily activities, being able to self-manage related to daily functioning and satisfaction of OT.
Time Frame
baseline, 4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR
Title
Patient's quality of life.
Description
The EuroQol-5D-5L(41) will be used to measure 'health-related quality of life' outcomes (HRQOL).The HRQOL is measured on 5 health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each health dimension has 5 severity levels ranging between no problems to extreme problems. The EQ- visual analogue scale (VAS) measures the persons' self-rated health on a scale from 0 to 100 (0= worst health and 100 the best health). The participants' EQ-5D-5L health states will be converted into utility values the Dutch tariff.
Time Frame
baseline,4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR
Title
Capability of older people
Description
The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. Unlike most profile measures used in economic evaluations, the ICECAP-O focuses on wellbeing defined in a broader sense, rather than health. The measure covers attributes of wellbeing that were found to be important to older people in the United Kingdom. ICECAP-O comprises five attributes (the lay terms are in brackets): Attachment (love and friendship), Security (thinking about the future without concern), Role (doing things that make participants feel valued), Enjoyment (enjoyment and pleasure), Control (independence). Score from 1 till 4 (1 = lowest and 4 = highest score
Time Frame
baseline,4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR
Title
Activity level
Description
The wearable activity monitor (PAM) will be applied to measure the amount of active movement in minutes per day.
Time Frame
up to 15 weeks
Title
Mobility functioning
Description
Time up and go test is a screening tool used to test basic mobility skills of frail elderly patients (60-90 years old) an persons with stroke.
Time Frame
baseline and 24 weeks after discharge GR
Title
Satisfaction with OT
Description
The Patient-Reported Outcome Measure - Occupational Therapy (PROM-OT) is developed to measure the outcome and quality of OT in the Netherlands from a client perspective. The PROM-OT contains 13 questions regarding the outcome of OT for the person (e.g. I can perform my daily activities, whether or not with help/devices (for example self-care, household, leisure, work) and using scoring with 11 point scale (0= lowest score and 10 = highest score). It focusses on daily activities, being able to self-manage related to daily functioning and satisfaction of OT.
Time Frame
baseline, 4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR
Title
Societal cost
Description
Costs will be measured from a societal perspective, meaning that all costs related to the intervention will be measured, irrespective of who pays or benefits from them. Cost will be measured using retrospective cost questionnaires administered after 12 weeks and 24 weeks.
Time Frame
12 weeks after discharge GR and 24 weeks after discharge GR
Other Pre-specified Outcome Measures:
Title
Sociodemographic characteristics
Description
age, gender, date and time of admission hospital or geriatric clinic, date of discharge, the highest level of education, marital status, and living arrangement (minimal Data Set)
Time Frame
baseline
Title
Chronic conditions
Description
will be measured by the Functional Comorbidity Index (FCI). The FCI is a sum of 18 self-reported comorbid conditions with a score of 0 to 18. A score of 0 indicating no comorbid illness and a score of 18 indicating the highest number of comorbid illnesses. Comorbidities assessed by the index include arthritis, hypertension, asthma, hearing impairment, visual impairment, gastrointestinal disease, chronic obstructive pulmonary disease/emphysema, osteoporosis, angina, anaemia, congestive heart failure or heart disease, heart attack, neurological disease, stroke/transient ischemic attack, peripheral vascular disease, diabetes mellitus (type I or II), depression, degenerative disc disease and obesity.
Time Frame
baseline and 24 weeks after discharge GR
Title
Cognitive functioning
Description
To classify the severity of cognitive impairment the Montreal Cognitive Assessment (MoCA) will be used. The MoCA is a 30-point test administered in 10 minutes. The MoCA assesses orientation, short-term memory, visuospatial abilities, attention/concentration, language, and aspects of executive functioning. Data on its psychometric properties are limited, but preliminary results suggest that it has good test-retest reliability (+/- 1 point) and internal consistency (0.83). During the feasibility study the investigators experienced participants with light cognitive impairments and the OTHER-intervention was very useful. De score off 16 is based on de feasibility study and literature. The cutoff point for MoCA is a critical point and debated in literature. MoCA uses the cutoff of 26 is inadequate for the stroke setting. Normality range from 19 till 22 in acute stroke phase.
Time Frame
baseline and 24 weeks after discharge GR

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: be able to walk a few steps with or without a walking device. 60 years or older an assessment score of at least 16 on the Montreal Cognitive Assessment (MoCA) an indication for follow up GR at home Exclusion Criteria: Who are terminally ill Who have severe aphasia; problems with understanding. Who has been assessed legally incapable by a geriatric doctor
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sanne Pellegrom, MSc.
Phone
0031621157667
Email
s.pellegrom@hva.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Margriet Pol, Dr
Phone
+31621156542
Email
m.c.pol@hva.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margo van Hartingsveldt, Dr.
Organizational Affiliation
Amsterdam University of Applied Sciences
Official's Role
Study Director
Facility Information:
Facility Name
TanteLouise
City
Bergen Op Zoom
State/Province
Brabant
ZIP/Postal Code
4613 AK
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katja Drost, Drs.
Phone
+31164713300
Email
katja.drost@tantelouise.nl
Facility Name
ZZG Herstelcentrum
City
Groesbeek
State/Province
Gerlderland
ZIP/Postal Code
6561 LE
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jules Kraaijkamp, MSc.
Phone
+31610149118
Email
j.kraaijkamp@zzgzorggroep.nl
Facility Name
Cicero Zorggroep
City
Brunssum
State/Province
Limburg
ZIP/Postal Code
6441 CR
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel Knubben, MSc.
Phone
+31654757270
Email
R.Knubben@cicerozorggroep.nl
Facility Name
Sevagram
City
Heerlen
State/Province
Limburg
ZIP/Postal Code
6419 PB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bob van Zon, MSc.
Phone
+31639083913
Email
Bob.vanzon@sevagram.nl
Facility Name
Zorgcirkel Westerhout
City
Alkmaar
State/Province
Noord-holland
ZIP/Postal Code
1814 DE
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marije Holstege, Dr.
Phone
+31623134401
Email
Marije.holstege@omring.nl
Facility Name
Omring locatie Lindendeal
City
Hoorn
State/Province
Noord-holland
ZIP/Postal Code
1624 AB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marije Holstege, Dr.
Phone
+31623134401
Email
Marije.holstege@omring.nl
Facility Name
Vivium Naardenheem
City
Naarden
State/Province
Noord-Holland
ZIP/Postal Code
1411 HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen Vreeburg, Dr
Phone
+31356954411
Email
e.vreeburg@vivium.nl

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Occupational Therapy at Home E-Rehabilitation (OTHER) for Persons Post-stroke

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