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

Stroke, Ischemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03648957
• Other study ID #: H-17040484
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: February 28, 2021

Study information

• Verified date: March 2021
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 28, 2021
• Est. primary completion date: April 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ischemia
• Ischemic Attack, Transient
• Stroke
• Stroke Hemorrhagic
• Stroke, Ischemic
• Transient Ischemic Attack

Intervention

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

Device:
• Activity tracker
Participants are encouraged to wear a activity tracker to monitor their physical activity

Locations

Country	Name	City	State
Denmark	Department of neurology, Nordsjællands Hospital	Hillerød

Sponsors (3)

Lead Sponsor	Collaborator
Nordsjaellands Hospital	Metropolitan University College, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	Waist/hip ratio	Ratio between waist- and hip circumference (cm)	At baseline (0 weeks) and end of intervention (12 weeks)
Other	Body mass index	Body weight relative to height	At baseline (0 weeks) and end of intervention (12 weeks)
Other	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)
Other	Self-reported health	Two item questionnaire	At baseline (0 weeks) and end of intervention (12 weeks)
Other	Incidence of vascular events	Incidence of new stroke, TIA, ischemic heart disease, or all-cause death (combined)	52 weeks
Primary	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	Recruitment rate	Proportion of eligible patients included in the study	12 weeks
Secondary	Adherence rate	Proportion of included participants adhering to and completing the study protocol	From baseline (0 weeks) until the end of intervention (12 weeks)