Lifestyle Counselling as Secondary Prevention in Patients With Minor Stroke and Transient Ischemic Attack
Primary Purpose
Stroke, Ischemic, Stroke Hemorrhagic, Transient Ischemic Attack
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Lifestyle counselling
Usual care
Activity tracker
Sponsored by
About this trial
This is an interventional treatment trial for Stroke, Ischemic
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)
Sites / Locations
- Department of neurology, Nordsjællands Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Behavioral intervention
Usual care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Systolic blood pressure
Change in resting systolic blood pressure from baseline to three months follow-up
Secondary Outcome Measures
Recruitment rate
Proportion of eligible patients included in the study
Adherence rate
Proportion of included participants adhering to and completing the study protocol
Full Information
NCT ID
NCT03648957
First Posted
August 14, 2018
Last Updated
March 2, 2021
Sponsor
Nordsjaellands Hospital
Collaborators
Rigshospitalet, Denmark, Metropolitan University College
1. Study Identification
Unique Protocol Identification Number
NCT03648957
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
April 8, 2020 (Actual)
Study Completion Date
February 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nordsjaellands Hospital
Collaborators
Rigshospitalet, Denmark, Metropolitan University College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Stroke Hemorrhagic, Transient Ischemic Attack
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counselling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Usual stroke care discharge session; including written and verbal encouragement to a healthy lifestyle.
Intervention Type
Device
Intervention Name(s)
Activity tracker
Intervention Description
Participants are encouraged to wear a activity tracker to monitor their physical activity
Primary Outcome Measure Information:
Title
Systolic blood pressure
Description
Change in resting systolic blood pressure from baseline to three months follow-up
Time Frame
At baseline (0 weeks) and end of intervention (12 weeks)
Secondary Outcome Measure Information:
Title
Recruitment rate
Description
Proportion of eligible patients included in the study
Time Frame
12 weeks
Title
Adherence rate
Description
Proportion of included participants adhering to and completing the study protocol
Time Frame
From baseline (0 weeks) until the end of intervention (12 weeks)
Other Pre-specified Outcome Measures:
Title
Tobacco smoking (Daily/weekly/rarely/has quit smoking/never smoked)
Description
Number of participants currently smoking tobacco (self-reported)
Time Frame
At baseline (0 weeks) and end of intervention (12 weeks)
Title
Physical activity (Self-reported time used on light/moderate/strenuous activity or exercise per week)
Description
Time used per week on physical activity (self-reported)
Time Frame
From baseline (0 weeks) until the end of intervention (12 weeks)
Title
Adherence to preventive medication
Description
Proportion of taken/missed doses of preventive medication within the last seven days; antithrombotic, anticoagulants, antihypertensiva & lipid-lowering drugs (self-reported)
Time Frame
Previous seven days until the end of the intervention (12 weeks)
Title
Waist/hip ratio
Description
Ratio between waist- and hip circumference (cm)
Time Frame
At baseline (0 weeks) and end of intervention (12 weeks)
Title
Body mass index
Description
Body weight relative to height
Time Frame
At baseline (0 weeks) and end of intervention (12 weeks)
Title
Fatigue (Fatigue Assessment Scale)
Description
10 item questionnaire with 5-level likert scales assessing health related fatigue and the impact of fatigue on everyday activity
Time Frame
At the end of the intervention (12 weeks)
Title
Self-reported health
Description
Two item questionnaire
Time Frame
At baseline (0 weeks) and end of intervention (12 weeks)
Title
Incidence of vascular events
Description
Incidence of new stroke, TIA, ischemic heart disease, or all-cause death (combined)
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Christensen, MD
Organizational Affiliation
Department of Neurology, Nordsjællands Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of neurology, Nordsjællands Hospital
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32226634
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.
Results Reference
derived
Learn more about this trial
Lifestyle Counselling as Secondary Prevention in Patients With Minor Stroke and Transient Ischemic Attack
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