Stroke, Ischemic, Stroke Hemorrhagic, Transient Ischemic Attack
Conditions
Brief summary
Interventions to improve health behaviour in patients with resent acute stroke are not well established. This study will evaluate the feasibility and effect of an early initiated counselling intervention targeting smoking, physical activity, and adherence to preventive medication, with regular follow-up sessions, in patients with acute minor stroke or transient ischemic attack who are discharged home.
Detailed description
Stroke is a significant cause of morbidity, mortality, and loss of independence worldwide. In Denmark 12,000 people have a stroke per year. About one fourth of patients admitted with a stroke have had previous strokes or transient ischemic attack (TIA). The risk of recurrent stroke is highest in the first weeks and decreasing with time. In the last decades there has been an increased focus on the importance of health behaviour in the public and among patients in relations to prevention of vascular diseases. There is solid scientific evidence of the harmful effects of lifestyle factors, such as smoking, physical inactivity, and alcohol overuse. Hypertension is one of the leading risk factors for vascular diseases, including stroke and TIA. Lowering of the blood pressure is therefore an essential part of stroke treatment. Smoking cessation, physical activity, and adherence to antihypertensive and antithrombotic medication is highly recommended in patients with minor stroke and TIA. There is still a lack of knowledge about how to support patients in making suitable choices to prevent recurrence and progression of their disease. Previous research has shown varying results and it is therefore difficult to point out any specific intervention or element of interventions which would be feasible to implement in clinical practice. The hypothesis of the study is that early client-centred patient counselling with repeated follow-up sessions after discharge can reduce the blood pressure through smoking cessation, physical activity, and improved adherence to preventive medication in patients with minor stroke and transient ischemic attacks compared to simple encouragement to lifestyle change. The overall purpose of our research is to develop effective and clinically feasible interventions to prevent recurrent strokes in patients with minor stroke and transient ischemic attacks, and identify unmet needs in the newly discharged patients and their relatives. The PhD study will comprise of 1) a randomized feasibility trial (n=40) aiming to test a combined behavioural and clinical intervention with follow-up sessions post-discharge with 3-4 weeks intervals in 12 weeks on reducing blood pressure in patients with minor stroke and transient ischemic attack 2) a qualitative study to explore the patients attitudes and experiences towards medicine adherence, lifestyle changes, social support, and self-efficacy.
Interventions
BEHAVIORALLifestyle counselling
First behavioral counselling session will be conducted before discharge and follow-up session will be offered with 3-4 weeks intervals either by telephone or in the outpatient clinic.
BEHAVIORALUsual care
Usual stroke care discharge session; including written and verbal encouragement to a healthy lifestyle.
DEVICEActivity tracker
Participants are encouraged to wear a activity tracker to monitor their physical activity
Sponsors
Rigshospitalet, Denmark
Metropolitan University College
Nordsjaellands Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, age ≥ 18 years old * Hospitalized patients with TIA (ICD-10 G45.9) or stroke (ICD-10 I61, I63, I64) with a Scandinavian Stroke Scale of 45-58. Diagnosis must by confirmed by a neurologist * Discharge to their own home * Able to give a valid written consent
Exclusion criteria
* Severe barriers to communication * Not able to use a telephone * Severe disability prior to the stroke (WHO Performance Status \>2; mobilised less than 50 % of the day) * Requiring specialized rehabilitation * Active abuse of alcohol or narcotics * Severe psychiatric illness (affective disease, dementia, schizophrenia, anxiety)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure | At baseline (0 weeks) and end of intervention (12 weeks) | Change in resting systolic blood pressure from baseline to three months follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence rate | From baseline (0 weeks) until the end of intervention (12 weeks) | Proportion of included participants adhering to and completing the study protocol |
| Recruitment rate | 12 weeks | Proportion of eligible patients included in the study |
Other
| Measure | Time frame | Description |
|---|---|---|
| Waist/hip ratio | At baseline (0 weeks) and end of intervention (12 weeks) | Ratio between waist- and hip circumference (cm) |
| Body mass index | At baseline (0 weeks) and end of intervention (12 weeks) | Body weight relative to height |
| Tobacco smoking (Daily/weekly/rarely/has quit smoking/never smoked) | At baseline (0 weeks) and end of intervention (12 weeks) | Number of participants currently smoking tobacco (self-reported) |
| Self-reported health | At baseline (0 weeks) and end of intervention (12 weeks) | Two item questionnaire |
| Incidence of vascular events | 52 weeks | Incidence of new stroke, TIA, ischemic heart disease, or all-cause death (combined) |
| Fatigue (Fatigue Assessment Scale) | At the end of the intervention (12 weeks) | 10 item questionnaire with 5-level likert scales assessing health related fatigue and the impact of fatigue on everyday activity |
| Physical activity (Self-reported time used on light/moderate/strenuous activity or exercise per week) | From baseline (0 weeks) until the end of intervention (12 weeks) | Time used per week on physical activity (self-reported) |
| Adherence to preventive medication | Previous seven days until the end of the intervention (12 weeks) | Proportion of taken/missed doses of preventive medication within the last seven days; antithrombotic, anticoagulants, antihypertensiva & lipid-lowering drugs (self-reported) |
Countries
Denmark
Outcome results
None listed