Clinical trial NCT03648957: Lifestyle Counselling as Secondary Prevention in Patients With Minor Stroke and Transient Ischemic Attack
Official title: Lifestyle Counselling as Secondary Prevention in Patients With Minor Stroke and Transient Ischemic Attack: A Randomized Controlled Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Stroke Hemorrhagic
Transient Ischemic Attack
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Metropolitan University College
First posted: 2018-08-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Systolic blood pressure
timeFrame: At baseline (0 weeks) and end of intervention (12 weeks)
Secondary outcomes:
measure: Recruitment rate
timeFrame: 12 weeks
measure: Adherence rate
timeFrame: From baseline (0 weeks) until the end of intervention (12 weeks)
Other outcomes:
measure: Tobacco smoking (Daily/weekly/rarely/has quit smoking/never smoked)
timeFrame: At baseline (0 weeks) and end of intervention (12 weeks)
measure: Physical activity (Self-reported time used on light/moderate/strenuous activity or exercise per week)
timeFrame: From baseline (0 weeks) until the end of intervention (12 weeks)
measure: Adherence to preventive medication
timeFrame: Previous seven days until the end of the intervention (12 weeks)
measure: Waist/hip ratio
timeFrame: At baseline (0 weeks) and end of intervention (12 weeks)
measure: Body mass index
timeFrame: At baseline (0 weeks) and end of intervention (12 weeks)
measure: Fatigue (Fatigue Assessment Scale)
timeFrame: At the end of the intervention (12 weeks)
measure: Self-reported health
timeFrame: At baseline (0 weeks) and end of intervention (12 weeks)
measure: Incidence of vascular events
timeFrame: 52 weeks
Locations:
city: Hillerød
country: Denmark
facility: Department of neurology, Nordsjællands Hospital
Study officials:
affiliation: Department of Neurology, Nordsjællands Hospital
name: Thomas Christensen, MD
role: STUDY_DIRECTOR
References:
citation: Liljehult J, Molsted S, Moller T, Overgaard D, Adamsen L, Jarden M, Christensen T. Lifestyle counselling as secondary prevention in patients with minor stroke and transient ischemic attack: study protocol for a randomized controlled pilot study. Pilot Feasibility Stud. 2020 Mar 25;6:40. doi: 10.1186/s40814-020-00583-4. eCollection 2020.