Condition category
Circulatory System
Date applied
19/03/2010
Date assigned
18/05/2010
Last edited
28/06/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jolanda van Haastregt

ORCID ID

Contact details

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

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. Inpatient’s 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 patient’s 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

http://ww.zonmw.nl

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

  1. 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.

Additional files

Editorial Notes