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Completed

NCT Number: NCT03648957

Lifestyle Counselling as Secondary Prevention in Patients With Minor Stroke and Transient Ischemic Attack

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of neurology, Nordsjællands Hospital

Hillerød, 3400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lifestyle counselling

Behavioral

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.

Usual Care

Behavioral

Usual stroke care discharge session; including written and verbal encouragement to a healthy lifestyle.

Activity Tracker

Device

Participants are encouraged to wear a activity tracker to monitor their physical activity

Primary outcomes

  1. Systolic blood pressure

    Time frame: At baseline (0 weeks) and end of intervention (12 weeks)

    Change in resting systolic blood pressure from baseline to three months follow-up

Secondary outcomes

  1. Recruitment rate

    Time frame: 12 weeks

    Proportion of eligible patients included in the study

  2. Adherence rate

    Time frame: From baseline (0 weeks) until the end of intervention (12 weeks)

    Proportion of included participants adhering to and completing the study protocol

Other outcomes

  1. Tobacco smoking (Daily/weekly/rarely/has quit smoking/never smoked)

    Time frame: At baseline (0 weeks) and end of intervention (12 weeks)

    Number of participants currently smoking tobacco (self-reported)

  2. Physical activity (Self-reported time used on light/moderate/strenuous activity or exercise per week)

    Time frame: From baseline (0 weeks) until the end of intervention (12 weeks)

    Time used per week on physical activity (self-reported)

  3. Adherence to preventive medication

    Time frame: 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)

  4. Waist/hip ratio

    Time frame: At baseline (0 weeks) and end of intervention (12 weeks)

    Ratio between waist- and hip circumference (cm)

  5. Body mass index

    Time frame: At baseline (0 weeks) and end of intervention (12 weeks)

    Body weight relative to height

  6. Fatigue (Fatigue Assessment Scale)

    Time frame: 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

  7. Self-reported health

    Time frame: At baseline (0 weeks) and end of intervention (12 weeks)

    Two item questionnaire

  8. Incidence of vascular events

    Time frame: 52 weeks

    Incidence of new stroke, TIA, ischemic heart disease, or all-cause death (combined)

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Collaborators

  • Metropolitan University College
  • Rigshospitalet, Denmark

Registry information

Official study title

Lifestyle Counselling as Secondary Prevention in Patients With Minor Stroke and Transient Ischemic Attack: A Randomized Controlled Feasibility Study

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Aug 28, 2018
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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