MAESTRO: Multidisciplinary Aftercare for Elderly with STROke

ISRCTN	ISRCTN62286281
DOI	https://doi.org/10.1186/ISRCTN62286281
Secondary identifying numbers	313070301

Submission date: 19/03/2010
Registration date: 18/05/2010
Last edited: 25/02/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jolanda van Haastregt
Scientific

Universiteitssingel 40
P.O. Box 616
6200 MD Maastricht
The Netherlands
Maastricht
6229 HR
Netherlands

Study information

Study design	Multicentre 2 arm interventional randomised controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
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
Study acronym	MAESTRO
Study objectives	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(s)	Ethical approval will be requested within a month
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/05/2010
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	256; 128 patients per group
Total final enrolment	92
Key inclusion criteria	1. Admitted to a stroke unit 2. Aged 65 or older
Key exclusion criteria	Unable to give informed consent
Date of first enrolment	01/05/2010
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

Netherlands

Study participating centre

Universiteitssingel 40

Maastricht
6229 HR
Netherlands

Sponsor information

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Government

Laan van Nieuw Oost-Indië 334
Den Haag
2593 CE
Netherlands

Website	http://ww.zonmw.nl
"ROR"	https://ror.org/01yaj9a77

Funders

Funder type

Government

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) - (grant number: 313070301)
Private sector organisation / Other non-profit organizations

Alternative name(s): Netherlands Organisation for Health Research and Development
Location: Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	31/12/2012		Yes	No
Results article	results	23/01/2020	27/01/2020	Yes	No
Results article	results	23/02/2021	25/02/2021	Yes	No

Editorial Notes

25/02/2021: Publication reference added.
27/01/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.