Telehealth Group Counseling and Preventive Care for Women

NCT06404515 | Completed

• 1 other identifier: 21-03023409
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Immediately Before and Immediately After Each Counseling Session, up to 12 weeks

Study Arms (1)

Telehealth Counseling

EXPERIMENTAL

Telehealth sessions

Other: Telehealth Group Counseling

Interventions

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.

Telehealth Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10022, United States

Location

Related Publications (12)

• 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.

  PMID: 29449443 BACKGROUND

• Mosca 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.

  PMID: 22064958 BACKGROUND

• Okunrintemi 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.

  PMID: 30561253 BACKGROUND

• Garcia 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.

  PMID: 27081110 BACKGROUND

• Fiscella 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.

  PMID: 18809810 BACKGROUND

• Tai-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.

  PMID: 17850524 BACKGROUND

• Duryee R. The efficacy of inpatient education after myocardial infarction. Heart Lung. 1992 May;21(3):217-25.

  PMID: 1592611 BACKGROUND

• Theis 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.

  PMID: 7600475 BACKGROUND

• Winslow 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.

  PMID: 8900334 BACKGROUND

• Kingsbury K. Taking AIM: how to teach primary and secondary prevention effectively. Can J Cardiol. 1998 Apr;14 Suppl A:22A-26A.

  PMID: 9594930 BACKGROUND

• US 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.

  PMID: 28697260 BACKGROUND

• Manocchia A. Telehealth: Enhancing Care through Technology. R I Med J (2013). 2020 Feb 3;103(1):18-20.

  PMID: 32013298 BACKGROUND

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction; ST Elevation Myocardial Infarction; Coronary Artery Disease; Acute Coronary Syndrome; Myocardial Infarction; Angina, Unstable; Chest Pain

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Angina Pectoris; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Diala Steitieh, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 8, 2024
• Study Start: July 10, 2024
• Primary Completion: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)