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OpenTrials
Completed

NCT Number: NCT06404515

Telehealth Group Counseling and Preventive Care for Women

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telehealth Group Counseling

Other

Group counseling for women via telehealth to provide educational materials about atherosclerotic heart disease and provide information about risk factors and modification of risk factors. Women then have an opportunity to discuss / ask questions.

Primary outcomes

  1. Change in patient's accessibility to care as assessed by Likert scale.

    Time frame: 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.

  2. Change in patient's understanding of their disease as assessed by Likert scale.

    Time frame: 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.

  3. Change in medication compliance as assessed by Likert scale.

    Time frame: 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.

  4. Change in overall patient satisfaction as assessed by Likert scale.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

Utilizing Telehealth Group Counseling Sessions to Improve the Process and Delivery of Secondary Preventive Care for Women With Atherosclerotic Cardiovascular Disease

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 8, 2024
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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