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

NCT05855226 | Recruiting DMC

• 1 other identifier: 80-86900-98-022
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 9

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:

1. 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)?
2. 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. 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. 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. 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. 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
7. 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)

Conditions

Stroke; eHealth; Occupational Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  The investigators assess the changes across three time points (one, three and six months)

Secondary Outcomes (8)

• Changes in Canadian Occupational Performance measure (COPM-s)

  baseline, 4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR

• Self-management

  baseline, 4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR

• Patient's quality of life.

  baseline,4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR

• Capability of older people

  baseline,4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR

• Activity level

  up to 15 weeks

Other Outcomes (3)

• Sociodemographic characteristics

  baseline

• Chronic conditions

  baseline and 24 weeks after discharge GR

• Cognitive functioning

  baseline and 24 weeks after discharge GR

Study Arms (2)

Care as usual

NO INTERVENTION

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

OTHER-intervention

EXPERIMENTAL

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.

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

Interventions

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

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

OTHER-intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be able to walk a few steps with or without a walking device.
• years or older
• an assessment score of at least 16 on the Montreal Cognitive Assessment (MoCA)
• an indication for follow up GR at home

You may not qualify if:

• Who are terminally ill
• Who have severe aphasia; problems with understanding.
• Who has been assessed legally incapable by a geriatric doctor

Sponsors & Collaborators

• Amsterdam University of Applied Sciences: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Amsterdam UMC: collaborator

Study Sites (9)

Behandelcentrum SZR

Tiel, Gelderland, 4003 CA, Netherlands

RECRUITING

ZZG Herstelcentrum

Groesbeek, Gerlderland, 6561 LE, Netherlands

RECRUITING

Cicero Zorggroep

Brunssum, Limburg, 6441 CR, Netherlands

RECRUITING

Sevagram

Heerlen, Limburg, 6419 PB, Netherlands

RECRUITING

TanteLouise

Bergen op Zoom, North Brabant, 4613 AK, Netherlands

RECRUITING

Hogeschool van Amsterdam

Amsterdam-Zuidoost, North Holland, 1105 BD, Netherlands

RECRUITING

GRZ Plus (2 locations, Omring and Zorgcirkel)

Hoorn, North Holland, 1624 AB, Netherlands

RECRUITING

Vivium Naardenheem

Naarden, North Holland, 1411 HB, Netherlands

RECRUITING

AxionContinu

Utrecht, Utrecht, 3526KJ, Netherlands

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Margo van Hartingsveldt, Dr.

  Amsterdam University of Applied Sciences

  STUDY DIRECTOR

Central Study Contacts

Sanne Pellegrom, MSc.

CONTACT

0031621157667; s.pellegrom@hva.nl

Margriet Pol, Dr

CONTACT

+31621156542; m.c.pol@hva.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc. of Health Science - Principal Investigator

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: May 11, 2023
• Study Start: March 13, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (9)