|- candidate number||8228|
|- NTR Number||NTR2412|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-jul-2010|
|- Secondary IDs||60-61900-98-319 ZonMw|
|- Public Title||Multidisciplinary Aftercare for Elderly with STROke (MAESTRO).|
|- Scientific Title||MAESTRO: the effects of a multidisciplinary care programme for elderly persons with stroke who are admitted to a nursing home for rehabilitation and return home after discharge. |
|- hypothesis||The multidisciplinary integrated care programme is effective in improving self-help, social participation and experienced quality of life of elderly stroke patients. And is effective on the reduction of burden of care of carers.
|- Healt Condition(s) or Problem(s) studied||Quality of life, Stroke, Aftercare, Participation|
|- Inclusion criteria||1. Admitted to a stroke-unit in a nursing home;|
2. 65 years or older;
3. Community-dwelling before admission to the nursing home.
|- Exclusion criteria||Patients who are incapacitated.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2010|
|- planned closingdate||31-dec-2012|
|- Target number of participants||256|
|- Interventions||The transmural integrated care programme consists of three care modules;|
1. Working on recovery and learning to deal with impairments;
2. Self-management after stroke;
3. Education programme for patients and carers.
The main goal of the programme is to give optimal support and treatment to as well the patients as the carers. This will be provided in the nursing home and at the patients home. The main objectives of the programme are improving self-help, social participation and quality of life of the patients. An other important objective is to reduce the burden of care of the carer. The programme has a duration of minimum 2 and maximum 6 months. The first care module will take place in the nursing home and the second care module at the patients' home. The part of the programme which wille take place in the nursng home will have a duration of minimum 1 and maximum 2 months. The part of the intervention at the patients' homes will have a duration (depending of the exact problem) of minimum 1 and maximum 4 months. The exact duration will be variabel and depending of the health status and further demands of the patient and the carer.
|- Primary outcome||Primairy outcome measures of the patients:|
1. Ability to live independently will be measured with the dutch version of the Frenchay Activity Index, the MODI-FAI;
2. Functional status will be measured with the Katz-15 questionnaire;
3. Perceived quality of life (disease specific) will be measured with the Stroke Specific Quality of Life Measure;
4. Social participation will be measured with the ĎImpact on participation en autonomy (IPA)í.
Pimairy outocme measures of the informal caregivers:
1. Objective care burden will be measured with the Erasmus iBMG meetinstrument;
2. Perceived care burden will be measured with the Self-Rated Burden Vas en Carer Quality of life questionnaire.
|- Secondary outcome||Secondary outcome measures of the patients:|
1. Perceived health will be measured with the RAND-36;
2. Perceived quality of life (general) will be measured with the RAND-36, a grade for the current life (Cantrilís Self Anchoring Ladder);
3. Psychological wellbeing will be measured with the RAND-36;
4. Social functioning will be measured with the RAND-36.
Secondary outcome measures of the informal caregivers:
1. Percieved quality of life wll be measured with the RAND-36 and a grade for the current life (Cantrilís Self Anchoring Ladder);
2. Perceived health will be measured with the RAND-36.
|- Timepoints||Both patients and their informal caregivers receive three measurement during a periode of 12 months. Data from the patients are collected by means of face to face and telephone interviews. Data from the informal caregivers are collected by means of self-administered questionnaires. For the patients allocted to the intervention group, after discharge, the new multidisciplinary integrated care programme will take place largely at the participants' home by a team of health care professionals.|
|- Trial web site||http://www.nazorgbijberoerte.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. MSc. Tom Vluggen|
|- CONTACT for SCIENTIFIC QUERIES||Drs. MSc. Tom Vluggen|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Stroke is one of the major causes of loss of independence, decreased quality of life and mortality among elderly people. Each year, about 41,000 people in the Netherlands suffer a stroke and the associated functional impairments. The incidence of stroke strongly increases with age. Among persons aged 65 to 69, the incidence of stroke is 5.1 per 1000 people, rising to 37.7 per 1000 among those aged 95 years or over. Due to the multidimensional problems related to stroke, care for stroke patients is complex, even more so for elderly stroke patients because of multimorbidity. The Dutch health council recently recommended that special attention be paid to older people with multimorbidity. Furthermore, the Dutch associations for stroke patients (Samen Verder) and people with non-congenital brain damage (Cerebraal)) also draw attention to an important problem in the care for this group of senior citizens: the lack of adequate aftercare after rehabilitation in a nursing home. Of those experiencing stroke about 85% is admitted to hospital. After discharge from hospital, 8% is admitted to a rehabilitation centre, and 15% to a nursing home for rehabilitation. The group of patients admitted to a nursing home is older, frailer and have more complex care needs compared to the younger, more vital patients referred to a rehabilitation centre. Both groups receive rehabilitation treatment for a certain period in order to be able to function (largely) independently again. Compared to younger stroke patients who continue rehabilitation at home through a tailor-made day care programme after discharge from the rehabilitation centre, care for elderly patients discharged from nursing homes is far less tailored to their specific individual situations and needs, while their health problems are substantially more complex. Elderly stroke patients usually receive primary healthcare after discharge from nursing homes. Cooperation between the various primary care professionals, however, is often limited, with the multidimensional health problems that in the subacute phase led to admission to a nursing home for multidisciplinary treatment being continued by individually working healthcare professionals. In general, however, these primary care professionals have insufficient experience with the required integrated treatment, care and support of older stroke patients with complex care needs. This lack of tailor-made, specialized aftercare following rehabilitation in nursing homes results in this patient group being insufficiently able to cope with the remaining physical, cognitive and/or psychosocial impairments in their home environment. This prevents them from performing normal day-to-day activities, fulfilling social roles and maintaining the achieved functional level. Besides having negative consequences for these patients, these problems may also increase the burden of care for their informal caregivers. In recent years, many studies have focused on improving the quality and coordination of care
for stroke patients. The results of these studies have led to considerable improvements in the continuity of care for stroke patients in the acute and subacute stages. Currently, in the Netherlands, about 70 stroke chains of care have been implemented in regular care, and many hospitals, nursing homes and rehabilitation centres now house specialised stroke units. But aftercare for stroke patients still receives insufficient attention.
Although the introduction of care coordinators in Dutch primary care has led to an improvement in the logistic coordination of care, this is still insufficient in view of the target groupís complex care needs, which prevents them from reaching and remaining optimal levels of functioning. |
|- Main changes (audit trail)|
|- RECORD||12-jul-2010 - 13-apr-2011|