ReStoRe: Clinical and cost-effectiveness of self-management strategies in stroke patients and their partners

Nowadays, the yearly incidence of stroke patients ranges between 34,000 and
41,000 in the Netherlands and an increase in the number of patients is expected
in the coming years due to the ageing population. The majority of these
patients return home after discharge from hospital or rehabilitation treatment.
However, a considerable number of these patients report significant long term
consequences concerning psychosocial functioning in terms of decreased quality
of life and life satisfaction , emotional complaints such as anxiety and
depression , and social reintegration problems such as problems in return to
work, social relations and leisure time .
At the moment, only a small proportion of the home living stroke patients
receive formal in- or outpatient supporting services after their discharge from
hospital or rehabilitation centre. In daily life, patients often rely on
informal carers, usually partners.

Therefore, it is important for both patients and caregivers to learn how to
deal, manage, cope and live with the long term consequences of the stroke and
the considerable impact on their lives. In other chronic patient groups
teaching patients self-management strategies resulting in active and realistic
goal setting was a successful approach. Several studies have suggested that
such interventions can also be effective for stroke patients.

The purpose of this study is to investigate the clinical effectiveness of a
self management group intervention for stroke patients with social
reintegration problems and their partners compared to a control group education
intervention. The main research questions are:

Does an intervention aimed at proactive coping strategies and self-management
result in an increased use of proactive coping strategies and increased
participation in society in terms of subjective experienced restriction in
stroke patients and their partners?

Additionally, does the self-management intervention lead to increased levels of
self-efficacy, participation in society in terms of objective frequency and
subjective satisfaction, life satisfaction, and quality of life, and less
emotional problems in stroke patients and partners, and to decreased levels of
burden in partners?


Next to this question related to the clinical effectiveness of this intervention
the economic impact will be examined:

*What are the additional costs and additional outcomes of the self management
intervention compared to the education intervention?

This study has a multi-centre randomized controlled trial design. At least 106
stroke patients, and their partners, will participate in this study. They will
be recruited based on case finding in the participating hospitals and
rehabilitation centres. Subjects who are involved in the study will be followed
for approximately 12 months. We expect that 10 hospitals/ rehabilitation
centers will participate in our study. The University Medical Centre Utrecht
(UMCU) already consented to participate.

The self-management intervention will last ten weeks comprising six two-hour
group sessions, and a two-hour booster session. Participants will discuss the
themes *lifestyle and fitness*, *social support and relations*, *participation
in society* and *coping with negative feelings*, and will formulate realistic
and feasible theme related goals according the five stage model of proactive
coping during this intervention. During the week following the session, action
plans will be executed and progression will be registered. If participants have
questions or fail to complete their homework, they can contact their therapist
by email. Group sessions will take place in groups of four patients, their
possible partners and two health care professionals. Therapists will receive a
guideline and participants will receive a workbook.

Participants are offered either the self management or the control
intervention; both have potential benefit. At the moment care as usual is no
care or only one or two follow up visits after discharge home. Measurements
will take place at four different moments (before treatment, after treatment
and at 3 and 9 months follow up). Measurements are conducted in the form of
self-report questionnaires. The baseline measurement (T0) will be conducted by
the researcher in a face-to-face interview in which the study is explained in
detail. The other measurements are conducted by sending the questionnaires to
the patients home (T1, T2 and T3). Patients and partners are asked to fill in
the questionnaires within 2 weeks. After this 2-week period, the researcher
contacts the participants to either thank them for their participation and/or
asks them to provide missing information if needed. There are no known risks
for subjects participating in this study. Subjects will participate in this
study for one year.