- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07430644
TotalCardiology Letters Study
A Proof-of-Concept Study Evaluating a Theory-Based Motivational Letter to Increase Attendance to a One-Year Post-Cardiac Rehabilitation Risk Factor Check
The goal of this study is to see if a theory-based motivational letter can increase attendance at a one-year post-cardiac rehabilitation (CR) appointment in adults who have finished a CR program. The main question it aims to answer is:
• Can a theory-based motivational letter increase attendance at one-year follow-up appointments?
Researchers will compare participants who received the letter to those who received care as usual to see if there are any differences in attendance and risk factor management.
Participants will:
- Get a letter approximately 6 months before their one-year follow-up or care as usual
- Attend any appointments as usual
- Do routine health checks during their visits
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2E 7C5
- TotalCardiology Rehabilitation
-
Calgary, Alberta, Canada, T2N 1N4
- Behavioural Medicine Lab
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults of age ≥18 years
- Have completed the 12-week TCR program (including the 12 week final visit)
- Have a pre-booked 1-year visit marked in their TCR patient chart
Exclusion Criteria:
- Patient program status is listed as "discharged" or "deceased"
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
|
|
|
Experimental: Letter Group
|
A theory-based motivational letter will be mailed to patients 6 months in advance of their one-year post-CR follow-up appointment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attendance at one-year post-CR follow-up appointment
Time Frame: From enrollment to the one-year post-CR follow-up appointment
|
The primary outcome will be whether participants attend their one-year post-CR risk factor assessment (assessed by binary, yes or no).
|
From enrollment to the one-year post-CR follow-up appointment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographics
Time Frame: From enrollment to the one-year post-CR follow-up appointment
|
Demographics (e.g.
sex, gender, age, etc.) will be assessed by TotalCardiology medical chart review.
|
From enrollment to the one-year post-CR follow-up appointment
|
|
Clinical Factors
Time Frame: From enrollment to the one-year post-CR follow-up appointment
|
Cardiovascular clinical factors will be assessed by TotalCardiology medical chart review.
|
From enrollment to the one-year post-CR follow-up appointment
|
|
Cardiovascular Risk Factors
Time Frame: From enrollment to the one-year post-CR follow-up appointment
|
Cardiovascular risk factors will be assessed by TotalCardiology medical chart review.
|
From enrollment to the one-year post-CR follow-up appointment
|
Collaborators and Investigators
Sponsor
Collaborators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB23-1586
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
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