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Care 4 Stroke program: Caregiver mediated exercises with e-health support for early supported discharge after stroke.


- candidate number15805
- NTR NumberNTR4300
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-dec-2013
- Secondary IDsNL34618.048.12 837001408 (ZonMw projectnummer)
- Public TitleCare 4 Stroke program: Caregiver mediated exercises with e-health support for early supported discharge after stroke.
- Scientific TitleCare 4 Stroke program: Caregiver mediated exercises with e-health support for early supported discharge after stroke.
- ACRONYMCare4Stroke
- hypothesisWe hypothesize that the CARE4STROKE program will:
1) be feasible and safe to execute;
2) allows ESD of patient to their own home setting with a significant reduced inpatient stay of 1 day for HSU and 7 days for RC/NH.
3) increase patients self-reported health status with concomitant reduced levels of caregiver burden and
4) enhance feelings of empowerment as perceived by patient and partner when compared to usual care..
- Healt Condition(s) or Problem(s) studiedStroke, Exercise therapy
- Inclusion criteria Inclusion criteria for the 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) being in the early rehabilitation phase (24 hours- 3 months)
6) living independently before the stroke
7) planned to be discharged home
8) being able to follow instructions (a MMSE score > 23 points)
9) Functional Ambulation Score (FAC) < 5
10) a score of <11 on the Hospital Anxiety and Depression Scale (HADS)
11) Motivated for CME

Inclusion criteria for the 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 Hospital Anxiety and Depression Scale (HADS)
6) medically stable and physically able to perform the exercises together with the patient.
7) No significant Caregiver Strain (<4 SCI)
- Exclusion criteriaExclusion criteria for both patient and caregiver will be serious comorbidity which interferes with participation.
To determine suitability of both patient and partner, an intake exercise session together with a trained therapist will be scheduled prior to inclusion. The therapist will check the inclusion/exclusion criteria and judge if the exercises can be done adequately and safely.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2014
- planned closingdate1-apr-2016
- Target number of participants66
- InterventionsThe CARE4STROKE programme consists of eight weeks of complementary exercise therapy done with a caregiver, next to the usual therapy. 31 standardized exercises are available, that can be customized per patient and caregiver to the individual situation. These exercises were devised in collaboration with movement scientists and physical therapists and were shown to be feasible and safe in preliminary informal exploratory patient-caregiver try-outs. The exercises can be presented in a book version with photo's and text or in an smartphone/ tablet app with video's and voiceover. Regular reminders to exercise can be given by the app. (see appendix for examples) The exercises are aimed at improving skills related to walking ability like sitting, standing and making transfers, or are supporting exercises to improve mobility, strength and balance. The patient and their caregiver are asked to do the exercises minimally 5 times a week for 30 minutes on at least both weekend days or the equivalent dosage with an adopted schedule. When the intervention is correctly performed patients will have a surplus of 150 minutes of caregiver mediated therapy a week. Patients and their caregiver will have a weekly session with a trained therapist. In this session, the participating couple will be instructed as to which exercises should be performed safely during the next week and evaluate the exercises done last week. All patients and caregivers will be supported by a handbook with instructions. The programme starts when the patient is admitted in Reade. When the discharge date of the patient is earlier than the finishing of the programme, the programme continues at home with monitoring from the treating therapist.

The participants in the control group will receive usual care according to the Dutch guidelines for patients with stroke and the Royal Dutch Guidelines of Physical Therapy.
- Primary outcome1) Lenth of Stay in the Hospital Stroke Unit, rehabilitation Centre or Nursing Home.
- Secondary outcome2) Self reported health status with the Stroke Impact Scale (SIS version 3.0)
3) Quality of life, measured with the EQ-5D.
4) Mobility, measured by the Rivermead mobility index (RMI)
5) Independence in performing basic activities of daily living, measured by the Barthel index (BI)
6) Walking ability, assessed with the 5 metre walking speed and the 6 minute walking test.
7) Extended Activities of daily living, measured by the Nottingham extended ADL (NEADL).
8) Functional outcome, measured by Modified Rankin Scale (MRS) dichotomised to good outcome (0-2) or poor outcome (3-6).
9) Balance, assessed with the Berg Balance Scale (BBS)

For the caregiver:
10) the experienced strain of the caregiver measured by the Expanded Caregiver strain index. (CSI +)
11) Quality of life, measured with the CareQOL.

For both:
12) Amount of (additional) practice done by the couples in the intervention and controlgroup, this will be measured with a diary (see appendix) Problems and adverse events like falls will also be recorded in the diary
13) Personal Opinion Questionnaire for empowerment.
14) Emotional functioning, measured with the Hospital Anxiety and Depression Scale (HADS).
15) Fatigue, measured by the fatigue severity scale.
16) Self-efficacy, measured by the general self-efficacy scale.
17) A cost diary, comprising questions on items such as consultation with neurologists, family doctors, paramedics, re-admission to hospitals or rehabilitation centres, drug use, home care and non-professional support.
- TimepointsOutcome measures will be measured at baseline prior randomization, after the eight week intervention period and at 12 weeks (follow up) by an independent assessor who is not involved in training. Length of stay in the rehabilitation center will be reported at discharge of the patient. Self reports in the diary will take place during the intervention.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. G. Kwakkel
- CONTACT for SCIENTIFIC QUERIESProf. Dr. G. Kwakkel
- Sponsor/Initiator VU University Medical Center, Department of Rehabilitation Medicine, Reade
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryRationale:
Several systematic reviews have indicated that additional exercise therapy and repetitive task training have a significant effect on functional outcome after stroke. 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 of stroke costs.
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: randomized controlled trial (RCT).
Study population: 66 stroke patients and their caregivers, admitted in Reade, centre for rehabilitation and rheumatology, the VU Medical Centre or Naarderheem Nursing Home will participate in this study. Intervention: Participants will be randomly allocated to either 8 weeks of the CARE4STROKE programme in addition to usual care or to 8 weeks of usual care. Main study parameters/endpoints: Primary measurements of outcome: 1) Length of Stay and 2) self-reported health-status with the Stroke Impact Scale (SIS version 3.0). 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, Nottingham Extended Activities of Daily Living and modified Rankin Scale. In addition patients will keep a diary within the e-health application 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, General self-efficacy scale and Personal Opinion Questionnaire for empowerment will be used. In addition each couple will use a cost diary.
- Main changes (audit trail)
- RECORD2-dec-2013 - 3-jan-2014


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