Telehealth Group Counseling and Preventive Care for Women

June 18, 2025 updated by: Weill Medical College of Cornell University

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Krista Vadaketh, MD
  • Phone Number: 646-962-5558
  • Email: kav9064@nyp.org

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10022
        • Weill Cornell Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Telehealth Counseling
Telehealth sessions
Other: Telehealth Group Counseling
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Immediately Before and Immediately After Each Counseling Session, up to 12 weeks
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.
Immediately Before and Immediately After Each Counseling Session, up to 12 weeks
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.
Immediately Before and Immediately After Each Counseling Session, up to 12 weeks
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.
Immediately Before and Immediately After Each Counseling Session, up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Weill Medical College of Cornell University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Diala Steitieh, MD, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 14, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 14, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-03023409

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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