The primary aim of this study is to evaluate the feasibility, clinical effectiveness and cost effectiveness of a caregiver mediated exercises programme combined with e-health services (CARE4STROKE+) to improve self-reported health status and reduce…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary measurements of outcome: 1) Length of Stay; 2) self-reported
health-status with the Stroke Impact Scale (SIS version 3.0) and 3)
Self-Efficacy for patient (Sef-Efficacy for Symptom Management Scal (SESx)) and
caregiver (Revised Scale for Caregiving Self-Efficacy (RSCSE)).
Secondary outcome
Secondary outcomes for included stroke patients are EuroQol-5D (EQ-5D), the
Barthel Index, Rivermead Mobility Index, Berg Balance Scale, 5 meter walking
speed, 6 minute walking test, Timed Up and Go Test, the Motricity Index (leg),
The Fugl-Meyer assessment (leg), Nottingham Extended Activities of Daily Living
and modified Rankin Scale. In order to track the daily activity, patients will
wear a wireless activity monitor on the wrist one week before and after the
intervention. In addition, patients keep a diary to record adherence to the
exercise program and emerging complications. Caregiver burden will be
evaluated with the Caregiver Strain Index and Carer Quality of Life Index. For
patients and caregivers the Hospital Anxiety and Depression Scale, Fatigue
Severity Scale, Family Assessment Device and Personal Opinion Questionnaire for
empowerment will be used. In addition each couple will use a cost diary.
Background summary
Several systematic reviews have indicated that additional exercise therapy and
repetitive task training have a significant effect on functional outcome after
brain injury. Guidelines therefore conclude that patients in a rehabilitation
setting should have the opportunity to get an increase of intensity of therapy.
At this moment resources in rehabilitation facilities are not sufficient to
meet these recommendations. A new method could be to involve caregivers
(partner, family, friends) in exercise training. Previous studies suggest that
this form of exercises done with a caregiver can lead to a better functional
outcome for the patient and less strain for the caregiver. A critical part will
be safety, adherence of the patient and caregiver and continuing support, for
which innovative e-health and structured tele-rehabilitation services could be
used.
In addition, a recent meta-analysis has shown that early supported discharge
with additional services in the community is beneficial for optimizing the
transition from the rehabilitation setting to the home situation and is
cost-effective by reducing the length of stay of inpatient services,
acknowledging that inpatient rehabilitation accounted for about 44% of all care
costs.
Study objective
The primary aim of this study is to evaluate the feasibility, clinical
effectiveness and cost effectiveness of a caregiver mediated exercises
programme combined with e-health services (CARE4STROKE+) to improve
self-reported health status and reduce the length of stay and costs by allowing
early supported discharge of stroke patients to their own home setting.
Study design
The present study has a randomized controlled trial design.
Intervention
Participants will be allocated to either 8 weeks of the CARE4STROKE+ programme
in addition to usual care or to 8 weeks of usual care.
Study burden and risks
Participants in the intervention group get a surplus of 150 minutes of exercise
training a week; Caregivers will be involved and will need to allocate time to
the programme as well. Care is taken to assure safe performance of the
exercises. This will be accomplished by e-health and tele-rehabilitation
services and safety instructions and close guidance and coaching of a
therapist. The control group will have no additional benefit or risks.
Assessments will take place at baseline, after the intervention and at twelve
weeks follow up. They consist of questionnaires and tests, taking approximately
two hours per assessment.
Overtoom 283
Amsterdam 1054HW
NL
Overtoom 283
Amsterdam 1054HW
NL
Listed location countries
Age
Inclusion criteria
Patient:
1) 18 years or older
2) written informed consent
3) able to understand the Dutch language (on sufficient level to understand instructions and complete the questionnaires)
4) knowing and able to appoint a caregiver who he/she wants to participate in the programme (with a maximum of two caregivers)
5) living independently before the acquired brain injury
6) planned to be discharged home
7) being able to follow instructions (a MMSE score > 18 points)
8) Functional Ambulation Score (FAC) < 5
9) a score of <11 on the domain 'depression' on the Hospital Anxiety and Depression Scale (HADS)
10) Motivated for CME
11) Diagnosis group of ABI caused by stroke, subarachnoid haemorrhage, trauma, status after cardiac arrest, encephalitis or postoperative status after brain tumor.Caregiver:
1) 18 years or older
2) written informed consent
3) able to understand the Dutch language (on sufficient level to understand instructions and complete the questionnaires)
4) sufficiently motivated for CME
5) a score of <11 on the domain 'depression' on the Hospital Anxiety and Depression Scale (HADS)
6) medically stable and physically able to perform the exercises together with the patient.
Exclusion criteria
For patient and caregiver:
Serious comorbidity which interferes with participation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL34618.048.12 |
| Other | TC=5055 |