POWER: family-centered rehabilitation |
|- candidate number||23933|
|- NTR Number||NTR5742|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-feb-2016|
|- Secondary IDs||60-63000-98-110 Dossiernumber ZonMW|
|- Public Title||POWER: family-centered rehabilitation |
|- Scientific Title||POWER: A multicenter controlled trial of the effect of Family Group Conferences for patients with amputation, acquired brain injury and spinal cord injury and their relatives
|- hypothesis||Family Group Conferences will improve disability-management self-efficacy and participation in patients with amputation, acquired brain injury and spinal cord injury and their relatives |
|- Healt Condition(s) or Problem(s) studied||Amputees, Acquired brain injury, Spinal Cord Injury|
|- Inclusion criteria||- Recent onset of spinal cord injury, acquired brain injury, or (leg) amputation|
- Expected clinical admission stay in the rehabilitation centre of at least 4 weeks
- Age at least 18 years
- For intervention participation: the patient and/or the informal caregiver has a below-average self-efficacy score (46 or lower on the ALCOS-12)
|- Exclusion criteria||- Full recovery or nearly full recovery of the patient is expected|
- No expected return to the home situation
- It is expected that outpatient treatment is in a different rehabilitation centre than the clinical treatment
- Patients cannot mention an informal caregiver / 'significant other'
- No informed consent of both the patient and the informal caregiver
- High degree of cognitive or intellectual problems (unreliable measurements);
- Participation in other intervention research.
- Limited life expectancy due to metastases
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||8-apr-2016|
|- planned closingdate||1-okt-2019|
|- Target number of participants||328|
|- Interventions||Patients and informal caregivers in the intervention centres who score low on self-efficacy (high-risk families) will receive the Family Group Conference, consisting of three meetings organised by social work. Aim of the Family Group Conference is to enhance disability-management self-efficacy and participation of the patient and the informal caregiver, with help of their social network. Patients and informal caregivers who score high on self-efficacy and the participating patient and informal caregiver dyads in the control centres receive regular care. |
|- Primary outcome||Disability-management self-efficacyv
|- Secondary outcome||Mood problems, burden of care giving, caregiver mastery, family functioning, life satisfaction, pain, fatigue, general health, mood, experienced continuity of care, care empowerment, provided assistance to patient / assistance from social network, time expenditure by social workers and psychologists and time required from social workers to organize and support FFC’s, care satisfaction, demographic factors, condition specific factors, functional status factors, personality, coping, psychological resources, social network, perceived social support|
|- Timepoints||Shortly after clinical admission in the rehabilitation centre, at discharge, 3 months after discharge and 6 months after discharge|
|- Trial web site||http://www.dehoogstraat.nl/onderzoek-innovatie/diagnoses/beroerte/power|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Eline Scholten|
|- CONTACT for SCIENTIFIC QUERIES|| Eline Scholten|
|- Sponsor/Initiator ||Center of Excellence for Rehabilitation Medicine, University Medical Center Utrecht, De Hoogstraat Rehabilitation, Utrecht|
(Source(s) of Monetary or Material Support)
|Fonds Nuts-Ohra, Revalidatiefonds, ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Background and objectives:
Empowerment of patients and their families, meaning enhancing their ability to handle the consequences of their condition adequately to participate in society, is an important goal of rehabilitation. However, for several reasons these efforts do not reach their goals. Research consistently shows that many patients and their families feel insufficiently equipped for their new life and perceive a discontinuity of care. The general aim of the POWER study is to improve upon current rehabilitation concerning empowerment of patients and their significant others. The specific aims of the study are to: (1) to develop and evaluate a systematic screening on risk factors in patients and their relatives(usually but not necessarily spouses) for long-term adjustment problems; (2) to evaluate a Family Group Conference (FGC) for families at risk on long-term adjustment problems, with at least two structured follow-up contacts with the family.
Dyads of patients with recent onset of brain injury, amputation or spinal cord injury and their relatives.
There is a comprehensive assessment of risk factors for long-term adjustment problems in patients and relatives in the first two weeks of admission. The assessment battery will cover the domains of mood, personality, coping strategies, psychological resources, lifestyle factors, existing social network and support and pre-injury social participation. The assessment battery functions as a screening instrument for ‘high risk’ families. The FGC intervention will only be implemented in ‘high risk’ families in the intervention centers. The FGC is an intervention consisting of three contact moments in which the family, supported by the social worker of the rehabilitation team, and relevant members of their social network (e.g., children, friends, colleagues) will come together to discuss the possible impacts of the condition on activities and participation of the family, to set priorities for support and to make action plans on how to achieve these priorities. The conference will be prepared by the social worker and the family together. Topics to be addressed and persons to be invited will be family-specific. The intervention will be evaluated in a parallel group trial. ‘Low risk’ families and families in the control centers will receive care as usual. All participating patients and their relatives will complete four questionnaires: at admission, at discharge, and after three and six months after discharge.
It will be evaluated if the FGC will enhance empowerment, operationalized as disability-management self-efficacy, and participation of patients and relatives. In addition, the assessment battery of potential risk factors will be evaluated.
|- Main changes (audit trail)|
|- RECORD||9-feb-2016 - 6-aug-2017|
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