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

NCT03648957 | Completed

• 1 other identifier: H-17040484
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic; Stroke Hemorrhagic; Transient Ischemic Attack

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Recruitment rate

  12 weeks

• Adherence rate

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

Other Outcomes (8)

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

  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)

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

• Adherence to preventive medication

  Previous seven days until the end of the intervention (12 weeks)

Study Arms (2)

Behavioral intervention

EXPERIMENTAL

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; Device: Activity tracker

Usual care

ACTIVE COMPARATOR

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

Interventions

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.

Behavioral intervention

Usual care BEHAVIORAL

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

Usual care

Activity tracker DEVICE

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

Behavioral intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nordsjaellands Hospital: lead
• Rigshospitalet, Denmark: collaborator
• Metropolitan University College: collaborator

Study Sites (1)

Department of neurology, Nordsjællands Hospital

Hillerød, 3400, Denmark

Location

Related Publications (2)

• Liljehult J, Molsted S, Moller T, Overgaard D, Christensen T. Lifestyle counselling as secondary prevention in patients with minor stroke or transient ischemic attack: a randomized controlled pilot study. Pilot Feasibility Stud. 2024 Mar 22;10(1):50. doi: 10.1186/s40814-024-01478-4.

  PMID: 38519983 DERIVED

• 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.

  PMID: 32226634 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke; Ischemic Attack, Transient

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• Thomas Christensen, MD

  Department of Neurology, Nordsjællands Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 28, 2018
• Study Start: October 1, 2018
• Primary Completion: April 8, 2020
• Study Completion: February 28, 2021
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)