NCT02207023

Brief Summary

The purpose of this study is to examine the efficacy of a lifestyle modification telehealth program on health-related behaviours in community-dwelling individuals living with stroke.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

May 8, 2020

Status Verified

March 1, 2020

Enrollment Period

5.5 years

First QC Date

July 28, 2014

Last Update Submit

May 5, 2020

Conditions

Keywords

StrokeTelehealthRehabilitationStroke CoachRandomized controlled trialLifestyle behavioursSecondary preventionChronic disease self-management

Outcome Measures

Primary Outcomes (1)

  • Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II)

    The 52-item Health Promoting Lifestyle Profile II provides a composite score of lifestyle, in the areas of: health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management.

    End of program (6 months)

Secondary Outcomes (10)

  • Daily walking physical activity

    End of program (6 months), and 6 months after the program ends (12 months from baseline)

  • Dietary behavior (26 items SmartDiet Questionnaire)

    End of program (6 months), and 6 months after the program ends (12 months from baseline)

  • Medication adherence (8-item Morisky Medication Adherence Scale)

    End of program (6 months), and 6 months after the program ends (12 months from baseline)

  • Depressive symptoms (20-item Centre for Epidemiological Studies-Depression [CES-D] Scale)

    End of program (6 months), and 6 months after the program ends (12 months from baseline)

  • Cognition (Montreal Cognitive Assessment [MoCA])

    End of program (6 months), and 6 months after the program ends (12 months from baseline)

  • +5 more secondary outcomes

Study Arms (2)

Memory Training Program

NO INTERVENTION

Participants will participate in 7 memory training coaching sessions (two in the first month) over a 6 month period. The coaching sessions will be administered by phone.

Healthy Lifestyle Training Program

EXPERIMENTAL

Participants will participate in 7 lifestyle coaching sessions (two in the first month) over a 6 month period. The coaching sessions will be administered by phone.

Behavioral: Healthy Lifestyle Training Program

Interventions

Study participants in the Healthy Lifestyle Training Program will each receive 7 lifestyle coaching telephone-sessions (30-60 minutes) with a trained lifestyle coach over a 6 month period. The lifestyle coaches will work on a 1:1 basis with each participant to encourage healthy lifestyles.

Healthy Lifestyle Training Program

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has experienced a stroke in the last 12 months
  • years of age or older
  • Living in the community with phone access
  • Mild to moderate stroke severity (i.e., modified Rankin Scale score ranging from 1 to 4)
  • Able to communicate in English

You may not qualify if:

  • Stroke of non-vascular origin
  • Actively engaged in formal stroke rehabilitation services
  • Uncontrolled arrhythmias
  • Significant musculoskeletal or other neurological condition
  • Severe aphasia or dysarthria
  • Not medically stable
  • Pain or co-morbidities which would preclude activity
  • Living in long-term residential care
  • Cognitive impairment, dependent in activities of daily living, and no caregiver participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

University Hospital of Northern BC

Prince George, British Columbia, V2M 1S2, Canada

Location

Surrey Memorial Hospital

Surrey, British Columbia, V3V 1Z2, Canada

Location

Holy Family Hospital

Vancouver, British Columbia, V5P 3L6, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

GF Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z 2G9, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (2)

  • Sakakibara BM, Lear SA, Barr SI, Goldsmith CH, Schneeberg A, Silverberg ND, Yao J, Eng JJ. Telehealth coaching to improve self-management for secondary prevention after stroke: A randomized controlled trial of Stroke Coach. Int J Stroke. 2022 Apr;17(4):455-464. doi: 10.1177/17474930211017699. Epub 2021 May 27.

  • Sakakibara BM, Lear SA, Barr SI, Benavente O, Goldsmith CH, Silverberg ND, Yao J, Eng JJ. A telehealth intervention to promote healthy lifestyles after stroke: The Stroke Coach protocol. Int J Stroke. 2018 Feb;13(2):217-222. doi: 10.1177/1747493017729266. Epub 2017 Sep 4.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Janice Eng, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 28, 2014

First Posted

August 1, 2014

Study Start

October 1, 2014

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

May 8, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations