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Clinical Trials/NCT02207023
NCT02207023
Completed
N/A

A Telehealth Intervention to Promote Chronic Disease Management After Stroke: A Pilot Randomized Controlled Study

University of British Columbia7 sites in 1 country126 target enrollmentOctober 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
University of British Columbia
Enrollment
126
Locations
7
Primary Endpoint
Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II)
Status
Completed
Last Updated
5 years ago

Overview

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.

Detailed Description

Participants recruited in this study will be randomly assigned to either the Healthy Lifestyle Training Program, or Attention Control Memory Training Program. Individuals 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. Individuals in the Memory Training Program will each receive 7 memory coaching telephone sessions (30-60 minutes) with a trained memory training coach over a 6 month period. 100 evaluable subjects will be recruited (124 to accommodate for 20% dropout).

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
March 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Janice Eng

Principal Investigator

University of British Columbia

Eligibility Criteria

Inclusion Criteria

  • Has experienced a stroke in the last 12 months
  • 50 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: End of program (6 months)

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.

Secondary Outcomes

  • Body composition (Body Mass Index, waist circumference)(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))
  • 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))
  • Daily walking physical activity(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))
  • Health-related quality of life (SF-36)(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))
  • Cardiovascular risk factors (resting blood pressure, lipid, and glucose profiles, C-Reactive Protein, Homocysteine).(End of program (6 months), and 6 months after the program ends (12 months from baseline))
  • Health and Social Services Utilization (Health and Social Service Utilization Inventory)(End of program (6 months), and 6 months after the program ends (12 months from baseline))
  • Global measure of lifestyle behavior (Health Promoting Lifestyle Profile II)(6 months after the program ends (12 months from baseline))

Study Sites (7)

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