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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03648957
Recruitment Status : Enrolling by invitation
First Posted : August 28, 2018
Last Update Posted : April 18, 2019
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Metropolitan University College
Information provided by (Responsible Party):
Nordsjaellands Hospital

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.

Condition or disease Intervention/treatment Phase
Stroke, Ischemic Stroke Hemorrhagic Transient Ischemic Attack Behavioral: Lifestyle counselling Behavioral: Usual care Device: Activity tracker Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lifestyle Counselling as Secondary Prevention in Patients With Minor Stroke and Transient Ischemic Attack: A Randomized Controlled Feasibility Study
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648957


Locations
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Denmark
Department of neurology, Nordsjællands Hospital
Hillerød, Denmark, 3400
Sponsors and Collaborators
Nordsjaellands Hospital
Rigshospitalet, Denmark
Metropolitan University College
Investigators
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Study Director: Thomas Christensen, MD Department of Neurology, Nordsjællands Hospital
  Study Documents (Full-Text)

Documents provided by Nordsjaellands Hospital:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nordsjaellands Hospital
ClinicalTrials.gov Identifier: NCT03648957    
Other Study ID Numbers: H-17040484
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Attack, Transient
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Ischemia