ASCVDNCT06404515
Telehealth Group Counseling and Preventive Care for Women
A study testing Telehealth Group Counseling in people with ASCVD and NSTEMI, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Telehealth Group Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2024to 14 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Women with risk factors (ex: HTN, HLD, DM) but no evidence of ASCVD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- ASCVD, NSTEMI, STEMI, Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction
- Being tested
- Telehealth Group Counseling
- Keywords
- ASCVD, NSTEMI, STEMI, Coronary Artery Disease, ACS, Myocardial Infarction, Unstable Angina, Chest Pain
- Medical subject headings
- Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction, Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction, Angina, Unstable, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth Group CounselingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth Counseling | Experimental | Telehealth sessions Receives: Other: Telehealth Group Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient's accessibility to care as assessed by Likert scale.
Score ranges from 0 to 5 with 0 being not satisfied and 5 being very satisfied.
Measured: 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.
Score ranges from 0 to 5 with 0 being not satisfied and 5 being very satisfied.
Measured: Immediately Before and Immediately After Each Counseling Session, up to 12 weeks
Change in medication compliance as assessed by Likert scale.
Score ranges from 0 to 5 with 0 being not likely and 5 being very likely.
Measured: Immediately Before and Immediately After Each Counseling Session, up to 12 weeks
Change in overall patient satisfaction as assessed by Likert scale.
Score ranges from 0 to 5 with 0 being not satisfied and 5 being very satisfied.
Measured: Immediately Before and Immediately After Each Counseling Session, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start10 Jul 2024
- Primary completion14 Nov 2024
- Study completion14 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for ASCVDStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diala Steitieh, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404515
- Sponsor's protocol ID
- 21-03023409
- Status last verified
- Jun 2025
- First submitted
- 30 Apr 2024
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aggarwal NR, Patel HN, Mehta LS, Sanghani RM, Lundberg GP, Lewis SJ, Mendelson MA, Wood MJ, Volgman AS, Mieres JH. Sex Differences in Ischemic Heart Disease: Advances, Obstacles, and Next Steps. Circ Cardiovasc Qual Outcomes. 2018 Feb;11(2):e004437. doi: 10.1161/CIRCOUTCOMES.117.004437.
PubMed 29449443Mosca L, Barrett-Connor E, Wenger NK. Sex/gender differences in cardiovascular disease prevention: what a difference a decade makes. Circulation. 2011 Nov 8;124(19):2145-54. doi: 10.1161/CIRCULATIONAHA.110.968792.
PubMed 22064958Okunrintemi V, Valero-Elizondo J, Patrick B, Salami J, Tibuakuu M, Ahmad S, Ogunmoroti O, Mahajan S, Khan SU, Gulati M, Nasir K, Michos ED. Gender Differences in Patient-Reported Outcomes Among Adults With Atherosclerotic Cardiovascular Disease. J Am Heart Assoc. 2018 Dec 18;7(24):e010498. doi: 10.1161/JAHA.118.010498.
PubMed 30561253Garcia M, Mulvagh SL, Merz CN, Buring JE, Manson JE. Cardiovascular Disease in Women: Clinical Perspectives. Circ Res. 2016 Apr 15;118(8):1273-93. doi: 10.1161/CIRCRESAHA.116.307547.
PubMed 27081110Fiscella K, Epstein RM. So much to do, so little time: care for the socially disadvantaged and the 15-minute visit. Arch Intern Med. 2008 Sep 22;168(17):1843-52. doi: 10.1001/archinte.168.17.1843.
PubMed 18809810Tai-Seale M, McGuire TG, Zhang W. Time allocation in primary care office visits. Health Serv Res. 2007 Oct;42(5):1871-94. doi: 10.1111/j.1475-6773.2006.00689.x.
PubMed 17850524Duryee R. The efficacy of inpatient education after myocardial infarction. Heart Lung. 1992 May;21(3):217-25.
PubMed 1592611Theis SL, Johnson JH. Strategies for teaching patients: a meta-analysis. Clin Nurse Spec. 1995 Mar;9(2):100-5, 120. doi: 10.1097/00002800-199503000-00010.
PubMed 7600475Winslow E, Bohannon N, Brunton SA, Mayhew HE. Lifestyle modification: weight control, exercise, and smoking cessation. Am J Med. 1996 Oct 8;101(4A):4A25S-31S; discussion 31S-33S. doi: 10.1016/s0002-9343(96)00317-8.
PubMed 8900334Kingsbury K. Taking AIM: how to teach primary and secondary prevention effectively. Can J Cardiol. 1998 Apr;14 Suppl A:22A-26A.
PubMed 9594930US Preventive Services Task Force; Grossman DC, Bibbins-Domingo K, Curry SJ, Barry MJ, Davidson KW, Doubeni CA, Epling JW Jr, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Phipps MG, Silverstein M, Simon MA, Tseng CW. Behavioral Counseling to Promote a Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults Without Cardiovascular Risk Factors: US Preventive Services Task Force Recommendation Statement. JAMA. 2017 Jul 11;318(2):167-174. doi: 10.1001/jama.2017.7171.
PubMed 28697260Manocchia A. Telehealth: Enhancing Care through Technology. R I Med J (2013). 2020 Feb 3;103(1):18-20.
PubMed 32013298
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Telehealth Group Counseling Sessions to Improve the Process and Delivery of Secondary Preventive Care for Women With Atherosclerotic Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT06404515
- Acronym / sponsor ID
- 21-03023409
- Conditions
- ASCVD, NSTEMI, STEMI, Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction
- Keywords
- ASCVD, NSTEMI, STEMI, Coronary Artery Disease, ACS, Myocardial Infarction, Unstable Angina, Chest Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Telehealth Counseling | Experimental | Other: Telehealth Group CounselingTelehealth sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Women with risk factors (ex: HTN, HLD, DM) but no evidence of ASCVD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth Group CounselingGroup 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. | Other | Telehealth Counseling |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Background: PubMed 29449443Aggarwal NR, Patel HN, Mehta LS, Sanghani RM, Lundberg GP, Lewis SJ, Mendelson MA, Wood MJ, Volgman AS, Mieres JH. Sex Differences in Ischemic Heart Disease: Advances, Obstacles, and Next Steps. Circ Cardiovasc Qual Outcomes. 2018 Feb;11(2):e004437. doi: 10.1161/CIRCOUTCOMES.117.004437.
- Background: PubMed 22064958Mosca L, Barrett-Connor E, Wenger NK. Sex/gender differences in cardiovascular disease prevention: what a difference a decade makes. Circulation. 2011 Nov 8;124(19):2145-54. doi: 10.1161/CIRCULATIONAHA.110.968792.
- Background: PubMed 30561253Okunrintemi V, Valero-Elizondo J, Patrick B, Salami J, Tibuakuu M, Ahmad S, Ogunmoroti O, Mahajan S, Khan SU, Gulati M, Nasir K, Michos ED. Gender Differences in Patient-Reported Outcomes Among Adults With Atherosclerotic Cardiovascular Disease. J Am Heart Assoc. 2018 Dec 18;7(24):e010498. doi: 10.1161/JAHA.118.010498.
- Background: PubMed 27081110Garcia M, Mulvagh SL, Merz CN, Buring JE, Manson JE. Cardiovascular Disease in Women: Clinical Perspectives. Circ Res. 2016 Apr 15;118(8):1273-93. doi: 10.1161/CIRCRESAHA.116.307547.
- Background: PubMed 18809810Fiscella K, Epstein RM. So much to do, so little time: care for the socially disadvantaged and the 15-minute visit. Arch Intern Med. 2008 Sep 22;168(17):1843-52. doi: 10.1001/archinte.168.17.1843.
- Background: PubMed 17850524Tai-Seale M, McGuire TG, Zhang W. Time allocation in primary care office visits. Health Serv Res. 2007 Oct;42(5):1871-94. doi: 10.1111/j.1475-6773.2006.00689.x.
- Background: PubMed 1592611Duryee R. The efficacy of inpatient education after myocardial infarction. Heart Lung. 1992 May;21(3):217-25.
- Background: PubMed 7600475Theis SL, Johnson JH. Strategies for teaching patients: a meta-analysis. Clin Nurse Spec. 1995 Mar;9(2):100-5, 120. doi: 10.1097/00002800-199503000-00010.
- Background: PubMed 8900334Winslow E, Bohannon N, Brunton SA, Mayhew HE. Lifestyle modification: weight control, exercise, and smoking cessation. Am J Med. 1996 Oct 8;101(4A):4A25S-31S; discussion 31S-33S. doi: 10.1016/s0002-9343(96)00317-8.
- Background: PubMed 9594930Kingsbury K. Taking AIM: how to teach primary and secondary prevention effectively. Can J Cardiol. 1998 Apr;14 Suppl A:22A-26A.
- Background: PubMed 28697260US Preventive Services Task Force; Grossman DC, Bibbins-Domingo K, Curry SJ, Barry MJ, Davidson KW, Doubeni CA, Epling JW Jr, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Phipps MG, Silverstein M, Simon MA, Tseng CW. Behavioral Counseling to Promote a Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults Without Cardiovascular Risk Factors: US Preventive Services Task Force Recommendation Statement. JAMA. 2017 Jul 11;318(2):167-174. doi: 10.1001/jama.2017.7171.
- Background: PubMed 32013298Manocchia A. Telehealth: Enhancing Care through Technology. R I Med J (2013). 2020 Feb 3;103(1):18-20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diala Steitieh, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth Group Counseling in people with ASCVD and NSTEMI, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06404515, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.