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The Healing Circles Project

Primary Purpose

Heart Diseases, Cardiovascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Healing Circles
Sponsored by
Simon Fraser University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Diseases focused on measuring internet, chronic disease management, technology, telehealth, application

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

(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.

Exclusion Criteria:

(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.

Sites / Locations

  • Kelowna General HospitalRecruiting
  • Northern Health Authority
  • St. Paul's HospitalRecruiting
  • Vancouver General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Healing Circles

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Health-related Quality of Life (EuroQol 5D5L)
In this 5-item questionnaire, participants will be asked to answer questions related to mobility, self-care, your usual activities, pain/discomfort, anxiety/depression.
Subjective Quality of Life (ICECAP-A)
In this 5-item questionnaire, participants will be asked to answer questions related to feeling settled and secure, love and friendship, independence, achievements, enjoyment and pleasure.
Health Resource Use (study specific questionnaire)
In this questionnaire, participants will be asked to answer questions about the heath services you have used in the past six months (e.g., health professional visits, hospitalizations, medication use, as well as work and time off of work due to health issues).

Full Information

First Posted
May 3, 2017
Last Updated
November 3, 2022
Sponsor
Simon Fraser University
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT03159325
Brief Title
The Healing Circles Project
Official Title
Delivery of Self-management Through a Peer-support Telehealth Intervention in Patients With Cardiovascular Disease: The Healing Circles Project
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2017 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Simon Fraser University
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Cardiovascular disease (CVD) is a leading cause of death and disability in Canada costing $22.2 billion annually in health care costs and lost productivity. Cardiovascular diseases are complex conditions that afflict older adults more so than any other population. As CVD is a chronic condition, many patients live with their disease and are affected by it on a daily basis in their homes and communities. Unfortunately, many patients 'suffer' in isolation. It is well-accepted that patient self-management plays a key role in improving patient health and reducing hospital admissions. Social and peer support, as well as timely access to credible information on managing CVD are essential for patient self-management. While there is a growing understanding that patients with CVD benefit from being actively engaged in their own care, questions remain as to where and how self management support should be delivered. Integration of self-management programs within the health care system has been a challenge due to the system emphasis on the management of acute and episodic conditions rather than the less intense and more drawn-out patient interactions characteristic of chronic conditions. Clearly alternatives are needed to support patient self-management and reduce needless hospital admissions. The rise in technology and telecommunications has opened up an array of possibilities for patients to be connected to their health while remaining in their homes and community. Outside of the health care sector, peer support and social networking have seen tremendous growth through the use of telecommunications. The value of these networks to improving health and self-management, however, has not been robustly studied. Through an existing partnership between university-based researchers, industry (Curatio), decision-makers (Vancouver Coastal Health), clinicians and patients the investigators have developed a peer support and self-management platform called Healing Circles. The investigator's 10-week pilot study of Healing Circles in patients with ischemic heart disease demonstrated the feasibility and acceptability, and resulted in key improvements to social support and self-management, as well as demonstrated ease of use of the application itself. The current proposal represents the next phase in our program to scale-up and spread the use of Healing Circles. The primary hypothesis is that patients with CVD using the Healing Circles platform will have improved self-management skills compared to patients receiving usual care. Secondary hypotheses are that participation in Healing Circles application will improve quality of life and health service use (and associated costs). Outcomes of end-user perceptions, attitudes and satisfaction with the platform will also be assessed. Participants (n=250) will be recruited through cardiology and cardiac outpatient clinics in Greater Vancouver, as well as through community presentations and mailouts. Patients with documented CVD, who have regular access to a device that supports Healing Circles (computer, tablet or smartphone) will be randomized to either the Healing Circles application or usual care and followed for up to a 2.5 year period. Healing Circles participants will form 'Circles' with 8 to 10 other participants to connect with and support one another as they learn to live day-to-day with their CVD. Patients also have the ability to connect and engage all members of the wider Healing Circles community. The investigators anticipate that participation in Healing Circles will support patient self-management for patients in their homes resulting in reduced need for health care and hospital use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases, Cardiovascular Diseases
Keywords
internet, chronic disease management, technology, telehealth, application

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
The usual care group will receive all standard treatment, instructions and information for patients with cardiovascular disease, but no Healing Circles program.
Arm Title
Healing Circles
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Healing Circles
Intervention Description
See description in the arm description.
Primary Outcome Measure Information:
Title
Changes from baseline in patient self-management (Health Education Impact Questionnaire v3.0) every 6 months until study end.
Description
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.
Time Frame
At baseline (0 years) and followed for 2.5 years, for a total of 2 to 6 assessments per subject
Secondary Outcome Measure Information:
Title
Health-related Quality of Life (EuroQol 5D5L)
Description
In this 5-item questionnaire, participants will be asked to answer questions related to mobility, self-care, your usual activities, pain/discomfort, anxiety/depression.
Time Frame
At baseline (0 years) and followed for 2.5 years, for a total of 2 to 6 assessments per subject
Title
Subjective Quality of Life (ICECAP-A)
Description
In this 5-item questionnaire, participants will be asked to answer questions related to feeling settled and secure, love and friendship, independence, achievements, enjoyment and pleasure.
Time Frame
At baseline (0 years) and followed for 2.5 years, for a total of 2 to 6 assessments per subject
Title
Health Resource Use (study specific questionnaire)
Description
In this questionnaire, participants will be asked to answer questions about the heath services you have used in the past six months (e.g., health professional visits, hospitalizations, medication use, as well as work and time off of work due to health issues).
Time Frame
At baseline (0 years) and followed for 2.5 years, for a total of 2 to 6 assessments per subject

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (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. Exclusion Criteria: (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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Lear, PhD
Phone
604-682-2344 ext. 62278
Email
slear@providencehealth.bc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Rochelle Nocos
Phone
604-806-8242
Email
rochelle_nocos@sfu.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Lear, PhD
Organizational Affiliation
Simon Fraser University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brodie Sakakibara, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
Facility Information:
Facility Name
Kelowna General Hospital
City
Kelowna
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rochelle Nocos
Phone
604-806-8242
Email
rochelle_nocos@sfu.ca
Facility Name
Northern Health Authority
City
Prince George
State/Province
British Columbia
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rochelle Nocos
Phone
604-806-8242
Email
rochelle_nocos@sfu.ca
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rochelle Nocos
Phone
604-806-8242
Email
rochelle_nocos@sfu.ca
First Name & Middle Initial & Last Name & Degree
Brodie Sakakibara
Phone
250-807-8505
Email
brodie@mail.ubc.ca
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rochelle Nocos
Phone
604-806-8242
Email
rochelle_nocos@sfu.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30635261
Citation
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.
Results Reference
derived

Learn more about this trial

The Healing Circles Project

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