Clinical trial NCT06404515: Telehealth Group Counseling and Preventive Care for Women
Official title: Utilizing Telehealth Group Counseling Sessions to Improve the Process and Delivery of Secondary Preventive Care for Women With Atherosclerotic Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ASCVD
NSTEMI
STEMI
Coronary Artery Disease
Acute Coronary Syndrome
Myocardial Infarction
Unstable Angina
Chest Pain
Keywords: ASCVD
NSTEMI
STEMI
Coronary Artery Disease
ACS
Myocardial Infarction
Unstable Angina
Chest Pain
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will participate in at least one telehealth session, lasting one hour, or up to five sessions lasting one hour each, over the course of 12 weeks.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion criteria:

* Female patients
* Age 18 and older
* Patients who are managed by providers at the Weill Cornell Medicine Women's Heart Program
* Women with evidence of atherosclerotic cardiovascular disease (ASCVD) and diagnoses of chest pain, myocardial infarction/heart attack (myocardial infarction - non ST elevation NSTEMI, ST elevation STEMI), coronary artery disease, acute coronary syndrome, unstable angina, atherosclerotic cardiovascular disease, hypertension (HTN), hyperlipidemia (HLD), diabetes (DM), and/or palpitations (as confirmed by clinician referral to study and chart review)

Exclusion criteria:

• Women with risk factors (ex: HTN, HLD, DM) but no evidence of ASCVD

Primary outcomes:
measure: Change in patient's accessibility to care as assessed by Likert scale.
timeFrame: Immediately Before and Immediately After Each Counseling Session, up to 12 weeks
measure: Change in patient's understanding of their disease as assessed by Likert scale.
timeFrame: Immediately Before and Immediately After Each Counseling Session, up to 12 weeks
measure: Change in medication compliance as assessed by Likert scale.
timeFrame: Immediately Before and Immediately After Each Counseling Session, up to 12 weeks
measure: Change in overall patient satisfaction as assessed by Likert scale.
timeFrame: Immediately Before and Immediately After Each Counseling Session, up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Diala Steitieh, MD
role: PRINCIPAL_INVESTIGATOR
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