NCT03159325

Brief Summary

Heart disease is a leading cause of death and disability in Canada. Providing social and peer supports has been proven to help patients manage their health and stay out of the hospital. The use of telehealth has opened up a wider possibility of patients receiving peer support while staying in their homes and communities. The investigators plan to study a new application for supporting patients through peer support. The application can be accessed by smartphone, tablet and desktop/laptop computer. Over two years, the investigators anticipate that the application (Healing Circles) will improve patient self care and reduce hospitalizations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
197

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 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

May 3, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

August 20, 2017

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

6.1 years

First QC Date

May 3, 2017

Last Update Submit

April 24, 2024

Conditions

Heart DiseasesCardiovascular Diseases

Keywords

internetchronic disease managementtechnologytelehealthapplication

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline in patient self-management (Health Education Impact Questionnaire v3.0) every 6 months until study end.

    In this 40 item questionnaire, participants will be asked to answer questions related to life engagement, health behaviours, skill acquisition, constructive attitudes, self-monitoring, health service navigation, social support, and emotional well-being.

    At baseline (0 years) and followed for 2.5 years, for a total of 2 to 6 assessments per subject

Secondary Outcomes (3)

  • Health-related Quality of Life (EuroQol 5D5L)

    At baseline (0 years) and followed for 2.5 years, for a total of 2 to 6 assessments per subject

  • Subjective Quality of Life (ICECAP-A)

    At baseline (0 years) and followed for 2.5 years, for a total of 2 to 6 assessments per subject

  • Health Resource Use (study specific questionnaire)

    At baseline (0 years) and followed for 2.5 years, for a total of 2 to 6 assessments per subject

Study Arms (2)

Usual Care

NO INTERVENTION

The usual care group will receive all standard treatment, instructions and information for patients with cardiovascular disease, but no Healing Circles program.

Healing Circles

EXPERIMENTAL

Healing Circles is an evidence-based and patient-informed novel self-management platform designed to support patients with CVD. It uses a private, secure social network that helps connect patients to one another, to personalized, disease management information , and provides functions to assist patients in self-management via evidence-based principles of behaviour change.

Behavioral: Healing Circles

Interventions

Healing CirclesBEHAVIORAL

See description in the arm description.

Healing Circles

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (i) men and women with CVD (ischemic heart disease, atrial fibrillation, heart failure and patients with implantable cardioverter-defibrillator); (ii) at least 18 years of age; (iii) own, or have regular access to, either a smartphone (Android or iOS operating system), tablet or laptop/desktop computer; and (iv) able to understand English.

You may not qualify if:

  • (i) patients with planned surgical intervention (will be approached after surgery); (ii) another household member in the study; and (iii) unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kelowna General Hospital

Kelowna, British Columbia, Canada

Location

Northern Health Authority

Prince George, British Columbia, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Related Publications (1)

  • Sakakibara BM, Chakrabarti S, Krahn A, Mackay MH, Sedlak T, Singer J, Whitehurst DG, Lear SA. Delivery of Peer Support Through a Self-Management mHealth Intervention (Healing Circles) in Patients With Cardiovascular Disease: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jan 11;8(1):e12322. doi: 10.2196/12322.

    PMID: 30635261DERIVED

MeSH Terms

Conditions

Heart DiseasesCardiovascular Diseases

Study Officials

  • Scott Lear, PhD

    Simon Fraser University

    PRINCIPAL INVESTIGATOR

  • Brodie Sakakibara, PhD

    University of British Columbia

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 3, 2017

First Posted

May 18, 2017

Study Start

August 20, 2017

Primary Completion

September 15, 2023

Study Completion

September 15, 2023

Last Updated

April 26, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(4)