Care4patient: caregiver mediated exercises with e-health support for early supported discharge after acquired brain injury. |
|- candidate number||21629|
|- NTR Number||NTR5055|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-feb-2015|
|- Secondary IDs||NL34618.048.12 60-63000-98-012 (ZonMw)|
|- Public Title||Care4patient: caregiver mediated exercises with e-health support for early supported discharge after acquired brain injury. |
|- Scientific Title||Care4patient: caregiver mediated exercises with e-health support for early supported discharge after acquired brain injury. |
|- hypothesis||We hypothesize that CARE4STROKE+ program will enhance |
- feelings of self-efficacy as perceived by patient and partner when compared to usual care.
- ADL dependency
- family functioning
|- Healt Condition(s) or Problem(s) studied||Aquired brain damage, Exercise therapy|
|- Inclusion criteria||Inclusion criteria for the patient:|
1) Diagnosis group of Acquired Brain Injury (ABI), caused by stroke, subarachnoid haemorrhage, trauma, status after cardiac arrest, encephalitis or postoperative status after brain tumor.
2) 18 years or older
3) written informed consent
4) able to understand the Dutch or English language (on sufficient level to understand instructions and complete the questionnaires)
5) knowing and able to appoint a caregiver who he/she wants to participate in the program (with a maximum of two caregivers)
6) living independently before ABI.
7) planned to be discharged home
8) being able to follow instructions (a MMSE score > 18 points)
9) Functional Ambulation Score (FAC) < 5
10) a score of <11 on the domain “depression” of 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 or English 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” of the Hospital Anxiety and Depression Scale (HADS)
6) medically stable and physically able to perform the exercises together with the patient.
|- Exclusion criteria||Exclusion 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 received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2015|
|- planned closingdate||1-apr-2018|
|- Target number of participants||2019|
|- Interventions||The intervention consists of eight weeks of complementary exercise therapy done with a caregiver, next to the usual therapy. 33 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 are presented in a 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 program starts when the patient is admitted in one of the participating centres. When the discharge date of the patient is earlier than the finishing of the program, the program 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 outcome||For the patient: Self-efficacy, measured with the Self-Efficacy for Symptom Management Scale (SESx) |
For the caregiver: Self-efficacy with the Revised Scale for Caregiving Self-Efficacy (RSCSE)
|- Secondary outcome||1) Length of Stay in the hospital, RC or NH, defined as the moment of admittance-moment of discharge. |
2) Self reported health status with SIS version 3.0)
3) Quality of life, measured with the EQ-5D.(34)
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 10 metre walking speed, the 6 minute walking test and the timed up and go test (TUG).(39;40)
7)Extended Activities of daily living, measured by the Nottingham extended ADL (NEADL).
8) Functional outcome, measured by Modified Rankin Scale (MRS)
9) Balance, assessed with the Berg Balance Scale (BBS).
10) Selectivity lower extremity, assessed with the Fugl Meyer (FM) lower extremity.
11)Strength of the lower limb, assessed with the Motricity Index (MI).
12)The amount of daily activity, assessed with a comfortable and wireless activity monitor on the wrist.
For the caregiver:
1)The experienced strain of the caregiver measured by the Expanded Caregiver strain index. (CSI +).
2) Quality of life, measured with the CareQOL.
1) Amount of (additional) practice done by the couples in the intervention and control group, this will be measured with a diary Problems and adverse events like falls will also be recorded in the diary
2) Personal Opinion Questionnaire for empowerment .
3) Emotional functioning, measured with the Hospital Anxiety and Depression Scale (HADS).
4)Fatigue, measured by the fatigue severity scale.
5)Family functioning, measured with the Family Assessment Device.
6) Participation, measured with the Utrecht Scale for Evaluation of Rehabilitation-‐Participation.
6) 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.
|- Timepoints||Outcome measures will be measured at baseline prior randomization, after the eight week intervention period and at 3 (week 12) and 6 months (week 26) follow up. |
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Rinske Nijland|
|- CONTACT for SCIENTIFIC QUERIES|| Rinske Nijland|
|- Sponsor/Initiator ||VU University Medical Center, Reade|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Rationale:
Several systematic reviews have indicated that additional exercise therapy and repetitive task training have a significant effect on functional outcome after acquired 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.
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 (1) improve self-reported health status, (2) the self-efficacy of patient and caregiver and (3) to 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: 88 patients with acquired brain injury and their caregivers, admitted in several rehabilitation centres, hospitals and nursing homes in the Netherlands will participate in this study.
Intervention: Participants will be randomly allocated to either 8 weeks of the CARE4STROKE+ program in addition to usual care or to 8 weeks of usual care.
Main study parameters/endpoints:
Primary measurements of outcome: 1) Length of Stay; 2) Self efficacy of patient with the Self-Efficacy for Symptom Management Scale (SESx) and self-efficacy of caregivers with the Revised Scale for Caregiver Self-Efficacy (RSCSE) and 3) self-reported health-status with the Self-reported Impact Scale (SIS version 3.0). Secondary measurements of outcome: 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, Utrecht Scale for Evaluation of Rehabilitation- Participation and Personal Opinion Questionnaire for empowerment will be used. In addition each couple will use a cost diary.
|- Main changes (audit trail)|
|- RECORD||2-feb-2015 - 25-apr-2015|
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