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

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

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.

Study Overview

• Status: Completed
• Conditions: Transient Ischemic Attack; Stroke, Ischemic; Stroke Hemorrhagic
• Intervention / Treatment: Behavioral: Lifestyle counselling; Device: Activity tracker; Behavioral: Usual care

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Department of neurology, Nordsjællands Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Behavioral intervention; Usual stroke service care plus additional lifestyle counselling focusing on smoking cessation, physical activity, and adherence to preventive medication. Regular follow-up sessions (3-4 weeks intervals). Physical activity is monitors by an activity tracker.	Behavioral: Lifestyle 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.; Device: Activity tracker; Participants are encouraged to wear a activity tracker to monitor their physical activity
ACTIVE_COMPARATOR: Usual care; Usual stroke service care; including computed tomography brain scan, neurological evaluation, and relevant cardiological/vascular evaluation (48-72 hour telemetry, echocardiography, carotic ultrasound imaging). At discharge all patients will receive written and verbal encouragement to a healthy lifestyle.	Behavioral: Usual care; Usual stroke care discharge session; including written and verbal encouragement to a healthy lifestyle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure	Change in resting systolic blood pressure from baseline to three months follow-up	At baseline (0 weeks) and end of intervention (12 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Proportion of eligible patients included in the study	12 weeks
Adherence rate	Proportion of included participants adhering to and completing the study protocol	From baseline (0 weeks) until the end of intervention (12 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco smoking (Daily/weekly/rarely/has quit smoking/never smoked)	Number of participants currently smoking tobacco (self-reported)	At baseline (0 weeks) and end of intervention (12 weeks)
Physical activity (Self-reported time used on light/moderate/strenuous activity or exercise per week)	Time used per week on physical activity (self-reported)	From baseline (0 weeks) until the end of intervention (12 weeks)
Adherence to preventive medication	Proportion of taken/missed doses of preventive medication within the last seven days; antithrombotic, anticoagulants, antihypertensiva & lipid-lowering drugs (self-reported)	Previous seven days until the end of the intervention (12 weeks)
Waist/hip ratio	Ratio between waist- and hip circumference (cm)	At baseline (0 weeks) and end of intervention (12 weeks)
Body mass index	Body weight relative to height	At baseline (0 weeks) and end of intervention (12 weeks)
Fatigue (Fatigue Assessment Scale)	10 item questionnaire with 5-level likert scales assessing health related fatigue and the impact of fatigue on everyday activity	At the end of the intervention (12 weeks)
Self-reported health	Two item questionnaire	At baseline (0 weeks) and end of intervention (12 weeks)
Incidence of vascular events	Incidence of new stroke, TIA, ischemic heart disease, or all-cause death (combined)	52 weeks

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Collaborators: Rigshospitalet, Denmark; Metropolitan University College
• Investigators: Study Director: Thomas Christensen, MD, Department of neurology, Nordsjællands Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ACTUAL): April 8, 2020
• Study Completion (ACTUAL): February 28, 2021

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (ACTUAL): August 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Ischemic Stroke; Ischemia; Ischemic Attack, Transient; Hemorrhagic Stroke
• Other Study ID Numbers: H-17040484

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No