Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
313070301
Study information
Scientific title
Effects of a patient-tailored multidisciplinary aftercare programme for elderly people discharged after rehabilitation in a nursing home: A multicentre randomised controlled trial
Acronym
MAESTRO
Study hypothesis
The following principal research questions will be answered in the effect evaluation:
1. Can the transmural integrated care programme improve elderly stroke patients ability to live independently, functioning, social participation, perceived quality of life, and care and treatment burden, as compared to usual care?
2. Can the transmural integrated care programme reduce caregiver strain as compared to usual care?
Ethics approval
Ethical approval will be requested within a month
Study design
Multicentre 2 arm interventional randomised controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Rehabilitation and aftercare after stroke
Intervention
Patients randomised to the intervention group will participate in a new Transmural Integrated Care (TIC) programme delivered by a multidisciplinary team of primary and tertiary (nursing home) care practitioners. This team will include a nursing home physician and a GP, as well as a physiotherapist, an occupational therapist, a speech therapist, a social worker, a dietician, a psychologist and a care coordinator. The programme is aimed at both patients and their informal caregivers.
The TIC programme will start directly after it is decided that a patient can be discharged to return home. An individual treatment plan will facilitate the transition from in- to outpatient rehabilitation care and guide further home-based rehabilitation. Inpatients goals for treatment will be continued during home-based rehabilitation. The TIC programme consists of two parts: a transition and reintegration phase.
This first part of the TIC programme will start during the patients stay in the nursing home and will continue at home after discharge. In this period the patient will make the transition form nursing home to living in the community. Therefore this part of the programme will partly take place in the nursing home and partly in the patients' home. An individual discharge plan will be set up at the nursing home, directly after it is decided that the patient will be discharged to return home. It will include all activities needed to ensure further care and treatment, as well as activities to facilitate procedures for necessary home adaptations and assisting devices. The multidimensional health problems as a result of stroke, which can have major implications for patients functioning in terms of locomotion, communication, cognition and emotional condition, require care delivered in an individually planned rehabilitation programme. The main treatment aim in this part of the TIC programme will be to improve patients daily functioning and stimulate them to live independently at home. During training, the focus will be on (re)learning the abilities needed for individual patients to function independently in their home environments. The patient is offered a training which even during the patients stay in the nursing home will be partly performed in the patients home. This unique possibility to practice in the context of patients own environments will facilitate their return. An additional treatment goal in this first part of the TIC programme is to prepare patients partner or other person for their role as caregivers. The transition part will take on average 1.5 months The reintegration part of the programme starts directly after the transition part. During this part of the TIC programme, in which possibilities for further functional progress are limited, the accent of treatment will switch to learning to cope with residual impairments as a result of stroke. Both patients and caregivers will be trained in improving their coping strategies and empowerment techniques based on self-management principles. The main aim of treatment is to improve the performance of daily activities and participation in society.
Education and patient support will form an important part of the programme. In cooperation with the patient organisation, an information course will be organised consisting of five meetings. The course will focus on consequences of stroke, perceived problems in living independently and returning to society, and the new role of the partner as caregiver.
Throughout the programme, goal attainment scaling will be used for goal setting during treatment. Goal attainment scaling appeared to be an appropriate method as a guide for rehabilitation treatment for elderly people. Treatment progress will be evaluated through regular team meetings. To facilitate the TIC programme an electronic dossier will be used. The reintegration part will take on average 3.5 months. The mean duration of the program will be on average 5 months.
Patients randomised to the control group will receive usual care.
The total duration of follow up will be 12 months
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Patients:
1.1. Daily activity, measured using the Frenchay Activity Index questionnaire
1.2. Level of functioning, measured using the Katz-15 questionnaire
1.3. Perceived quality of life, measured using the Stroke Specific Quality of Life Questionnaire
1.4. Participation, measured using the Impact on Participation and Autonomy questionnaire
2. Informal caregivers:
2.1. Objective informal caregivers' care load, measured using the Erasmus iBMG questionnaire
2.2. Perceived informal caregivers' care load, measured using the Self-Rated Burden Visual Analogue Scale and the Carer Quality Of Life questionnaire
2.3. Perceived quality of life, measured using the RAND-36 questionnaire
2.4. Perceived health, measured using the RAND-36 questionnaire
All outcomes will be measured at baseline, 6 months and 12 months
Secondary outcome measures
Patients:
1. Perceived health
2. Mental wellbeing
3. Social functioning
All outcomes measured at baseline, 6 months and 12 months using the RAND-36 questionnaire
Overall trial start date
01/05/2010
Overall trial end date
31/12/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Admitted to a stroke unit
2. Aged 65 or older
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
256; 128 patients per group
Participant exclusion criteria
Unable to give informed consent
Recruitment start date
01/05/2010
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Netherlands
Trial participating centre
Universiteitssingel 40
Maastricht
6229 HR
Netherlands
Sponsor information
Organisation
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Sponsor details
Laan van Nieuw Oost-Indië 334
Den Haag
2593 CE
Netherlands
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) - (grant number: 313070301)
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23273217
Publication citations
-
Protocol
Vluggen TP, van Haastregt JC, Verbunt JA, Keijsers EJ, Schols JM, Multidisciplinary transmural rehabilitation for older persons with a stroke: the design of a randomised controlled trial., BMC Neurol, 2012, 12, 164, doi: 10.1186/1471-2377-12-164.