- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04492527
Student-delivered Telehealth Program for COVID-19 Education and Health Promotion
A Student-delivered Community Outreach teleheAlth Program for Covid Education and Health Promotion (COACH)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The novel coronavirus (COVID-19) outbreak has made the world transition to practices of quarantine, social distancing and social isolation. While they serve as prevention strategies for COVID-19, they may also cause an increase of other health problems. As well, closures of public areas and financial challenges act as barriers to exercise and dietary quality. Thus quarantine-type strategies, while needed, compromise the ability to self-manage one's health and increase their risk of adverse health events.
Evidence suggests the negative effects of such quarantine-type strategies are especially being felt among Canada's seniors. A recent report by Statistics Canada indicates that 60% of Canadians, ≥65 years of age are 'very' concerned about their health due to social and economic consequences of COVID-19. Moreover, 80% of individuals reported being 'very' anxious about overloading the health system. This may in turn lead to rash decisions not to access health services as needed. Clearly, efforts are required to support older individuals to optimally manage their health to prevent disease and disability.
In British Columbia (BC), various specialized health resources have emerged to support people during the COVID-19 pandemic. However, many are passive in that they require individuals to initiate contact in response to a concern, and none have a specific focus on health promotion or disease prevention and management.
This study will ensure that community-living adults ages 65 years and older are effectively managing their health during these unprecedented times. Participants will receive a kit containing a self-help manual, a Health Report Card, and COVID-19 education. They will also received 6 telephone/video conference sessions with a student-coach who will utilize motivational interviewing techniques to foster lifestyle modification, and self-management.
Objectives:
- To quantitatively evaluate the effect of the two-month, six session (30-45 minutes/session) COACH program on health self-management, measured using the Health Directed Behaviour subscale in the Health Education Impact Questionnaire (heiQ),9 among community-living adults ≥65 years of age.
- To qualitatively describe the subjective experiences of participants receiving the COACH program.
Hypotheses:
- COACH will improve health directed behaviour in community-living adults, ≥65 years of age.
- COACH will also improve secondary outcomes in the areas of mood, social support, health-related quality of life, health promotion self-efficacy, and other self- management domains in the heiQ.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6T 1Z4
- University of British Columbia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age 65 years or older
- living within a community in British Columbia
- have access to a telephone or video conferencing program
- able to communicate in English
- have had no previous COVID-19 diagnosis by health professionals
- have cognitive-communicative ability to participate as per clinical judgement
- can provide informed consent
Exclusion Criteria:
- not medically stable
- are participating in other health promotion programs
- have severe hearing loss
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Telehealth coaching sessions
Receives the Telehealth-delivered coaching sessions.
|
Participants will be receiving a 2-month coaching session intervention that will be delivered via telephone or video-conferencing.
Each of the 6 sessions will be 30-45minutes long and one-on-one with a student coach.
In each session, coaches will review the participants' health behaviours and assess their knowledge about behavioural risks factors for chronic diseases and their current behaviours.
The coaches will then provide information about the health risks of poor health behaviours, and benefits of change.
Health behavioural goals will be established through a collaborative process.
The coaches will then assist participants to develop readily achievable action plans that participants will follow in between coaching sessions as a means to realize their health goals.
Adherence and modifications to the action plans will be discussed at the follow-up coaching session to promote health accountability.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline: Health Directed Behaviour at 2 months
Time Frame: Baseline, Post-intervention (immediately after the 2-month intervention)
|
Health Education Impact Questionnaire (HeiQ) that evaluates health directed behaviour for chronic disease management.
|
Baseline, Post-intervention (immediately after the 2-month intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression, Anxiety, Stress Scale
Time Frame: Baseline, Post-intervention (immediately after the 2-month intervention)
|
21-item survey scale that looks at perceived depression, anxiety and stress.
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Baseline, Post-intervention (immediately after the 2-month intervention)
|
Medical Outcomes Study (MOS): Social Support Survey
Time Frame: Baseline, Post-intervention (immediately after the 2-month session)
|
19-item survey that evaluates perceived social support.
|
Baseline, Post-intervention (immediately after the 2-month session)
|
Medical Outcomes Study (MOS): Short Form-36
Time Frame: Baseline, Post-intervention (immediately after the 2-month session)
|
Survey scale that evaluates at health-related quality of life.
|
Baseline, Post-intervention (immediately after the 2-month session)
|
Self-Rated Abilities for Health Practices Scale
Time Frame: Baseline, Post-intervention (immediately after the 2-month session)
|
28-item survey scale that looks at health promotion self-efficacy.
|
Baseline, Post-intervention (immediately after the 2-month session)
|
Self-management
Time Frame: Baseline, Post-intervention (immediately after the 2-month session)
|
Health Education Impact Questionnaire
|
Baseline, Post-intervention (immediately after the 2-month session)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brodie Sakakibara, PhD, University of British Columbia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COACH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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