Clinical trial NCT05855226: Effect of Occupational Therapy at Home E-Rehabilitation (OTHER) for Persons Post-stroke
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
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
eHealth
Occupational Therapy
Lead sponsor: Amsterdam University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Amsterdam UMC
First posted: 2023-05-11
Enrollment: 180
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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. 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 .


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

Primary outcomes:
measure: Changes in Canadian Occupational Performance measure (COPM-p) at three time points
timeFrame: The investigators assess the changes across three time points (one, three and six months)
Secondary outcomes:
measure: Changes in Canadian Occupational Performance measure (COPM-s)
timeFrame: baseline, 4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR
measure: Self-management
timeFrame: baseline, 4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR
measure: Patient's quality of life.
timeFrame: baseline,4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR
measure: Capability of older people
timeFrame: baseline,4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR
measure: Activity level
timeFrame: up to 15 weeks
measure: Mobility functioning
timeFrame: baseline and 24 weeks after discharge GR
measure: Satisfaction with OT
timeFrame: baseline, 4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR
measure: Societal cost
timeFrame: 12 weeks after discharge GR and 24 weeks after discharge GR
Other outcomes:
measure: Sociodemographic characteristics
timeFrame: baseline
measure: Chronic conditions
timeFrame: baseline and 24 weeks after discharge GR
measure: Cognitive functioning
timeFrame: baseline and 24 weeks after discharge GR
Locations:
city: Bergen Op Zoom
country: Netherlands
facility: TanteLouise
state: Brabant
city: Tiel
country: Netherlands
facility: Behandelcentrum SZR
state: Gelderland
city: Groesbeek
country: Netherlands
facility: ZZG Herstelcentrum
state: Gerlderland
city: Brunssum
country: Netherlands
facility: Cicero Zorggroep
state: Limburg
city: Heerlen
country: Netherlands
facility: Sevagram
state: Limburg
city: Amsterdam-Zuidoost
country: Netherlands
facility: Hogeschool van Amsterdam
state: Noord-Holland
city: Hoorn
country: Netherlands
facility: GRZ Plus
state: Noord-holland
city: Naarden
country: Netherlands
facility: Vivium Naardenheem
state: Noord-Holland
city: Utrecht
country: Netherlands
facility: AxionContinu
Study officials:
affiliation: Amsterdam University of Applied Sciences
name: Margo van Hartingsveldt, Dr.
role: STUDY_DIRECTOR
References: