Telehealth Group Counseling and Preventive Care for Women

Not Applicable

Recruiting

• Conditions: NSTEMI; STEMI; Coronary Artery Disease; ASCVD; Chest Pain; Acute Coronary Syndrome; Myocardial Infarction; Unstable Angina
• Interventions: Other: Telehealth Group Counseling

• Registration Number: NCT06404515
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

The purpose of this study is to utilize an innovative healthcare delivery strategy via telehealth group counseling sessions to improve engagement, adherence, and ultimately outcomes in female patients with atherosclerotic cardiovascular disease (ASCVD).

Detailed Description

This will be an electronic survey study of female patients with known atherosclerotic cardiovascular disease (ASCVD) who are managed by providers in the Weill Cornell Medicine Cardiology Division and self-select into this telehealth group education series. Group health counseling will be administered via the Weill Cornell Medicine approved telehealth platform at the time of participation. Participants will have the option to choose the session topic of their choice and will have the opportunity to participate in 1-5 sessions over 12 weeks, depending on their preference. Each session will occur regardless of number of participants but will be capped at 12 participants, anticipating that two will not join. Once consent is obtained, baseline characteristics of participants will be collected via chart review. Demographics such as age, race, insurance carrier, and clinician-documented diagnoses, such as ASCVD, hypertension (HTN), hyperlipidemia (HLD), and diabetes mellitus (DM), will be collected. Prior to each group health counseling session, an initial survey will be provided to patients who are chosen for and consent to this study. This survey will ask patients about their demographics, self-reported diagnoses, current level of satisfaction about their understanding of their diagnoses, reasons for participating in the study, and history of previous participation in telehealth group counseling. After the sessions, a post-session survey will be provided to all participants and will assess patient understanding, including diagnoses and medications, satisfaction with the format, satisfaction with the provider, how many sessions were attended, reasons for attending more than one session, and recommendation of this format to others. All data will be de-identified prior to analysis and will remain confidential among investigators.

Study Timeline

• Study First Submitted: 2024-04-30
• Study First Submitted QC: 2024-05-06
• Study First Posted: 2024-05-08
• Status Verified: 2024-07
• Study Start: 2024-07-10
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-24
• Primary Completion: 2025-04-26
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telehealth Counseling	Telehealth Group Counseling	Telehealth sessions

Primary Outcome Measures

Name	Time	Method
Change in patient's understanding of their disease as assessed by Likert scale.	Immediately Before and Immediately After Each Counseling Session, up to 12 weeks	Score ranges from 0 to 5 with 0 being not satisfied and 5 being very satisfied.
Change in patient's accessibility to care as assessed by Likert scale.	Immediately Before and Immediately After Each Counseling Session, up to 12 weeks	Score ranges from 0 to 5 with 0 being not satisfied and 5 being very satisfied.
Change in medication compliance as assessed by Likert scale.	Immediately Before and Immediately After Each Counseling Session, up to 12 weeks	Score ranges from 0 to 5 with 0 being not likely and 5 being very likely.
Change in overall patient satisfaction as assessed by Likert scale.	Immediately Before and Immediately After Each Counseling Session, up to 12 weeks	Score ranges from 0 to 5 with 0 being not satisfied and 5 being very satisfied.

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States