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

NCT ID: NCT05855226

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-13

Study Completion Date

2026-01-31

Brief Summary

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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:

1. 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:
2. 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)
3. 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)
4. 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)
5. 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).
6. 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
7. 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 .

Detailed Description

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Conditions

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Stroke eHealth Occupational Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Care as usual

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

Group Type NO_INTERVENTION

No interventions assigned to this group

OTHER-intervention

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

Group Type EXPERIMENTAL

OTHER-intervention (Occupational Therapy at Home E-Rehabilitation)

Intervention Type OTHER

The occupational therapist will use activity monitoring and coaching techniques with videoconference during OTHER.

Interventions

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OTHER-intervention (Occupational Therapy at Home E-Rehabilitation)

The occupational therapist will use activity monitoring and coaching techniques with videoconference during OTHER.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Amsterdam UMC

OTHER

Sponsor Role collaborator

Amsterdam University of Applied Sciences

OTHER

Sponsor Role lead

Responsible Party

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Sanne Pellegrom

MSc. of Health Science - Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Margo van Hartingsveldt, Dr.

Role: STUDY_DIRECTOR

Amsterdam University of Applied Sciences

Locations

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Behandelcentrum SZR

Tiel, Gelderland, Netherlands

Site Status RECRUITING

ZZG Herstelcentrum

Groesbeek, Gerlderland, Netherlands

Site Status RECRUITING

Cicero Zorggroep

Brunssum, Limburg, Netherlands

Site Status RECRUITING

Sevagram

Heerlen, Limburg, Netherlands

Site Status RECRUITING

TanteLouise

Bergen op Zoom, North Brabant, Netherlands

Site Status RECRUITING

Hogeschool van Amsterdam

Amsterdam-Zuidoost, North Holland, Netherlands

Site Status RECRUITING

GRZ Plus (2 locations, Omring and Zorgcirkel)

Hoorn, North Holland, Netherlands

Site Status RECRUITING

Vivium Naardenheem

Naarden, North Holland, Netherlands

Site Status RECRUITING

AxionContinu

Utrecht, Utrecht, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Sanne Pellegrom, MSc.

Role: CONTACT

0031621157667

Margriet Pol, Dr

Role: CONTACT

+31621156542

Facility Contacts

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Lucienne Schreurs

Role: primary

0344671650

Jules Kraaijkamp, MSc.

Role: primary

+31610149118

Bianca Miltenburg, MSc.

Role: primary

+31657319622

Bob van Zon, MSc.

Role: primary

+31639083913

Katja Drost, Drs.

Role: primary

+31164713300

Sanne Pellegrom

Role: primary

0621157667

Marije Holstege, Dr.

Role: primary

+31623134401

Ellen Vreeburg, Dr

Role: primary

+31356954411

Marieke Geerars

Role: primary

0640901688

Other Identifiers

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80-86900-98-022

Identifier Type: -

Identifier Source: org_study_id

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