Telehealth Group Counseling and Preventive Care for Women

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06404515
• Other study ID #: 21-03023409
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 24, 2024
• Est. completion date: October 31, 2025

Study information

• Verified date: May 2024
• Source: Weill Medical College of Cornell University
• Contact: Krista Vadaketh, MD
• Phone: 646-962-5558
• Email: kav9064[@]nyp.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 31, 2025
• Est. primary completion date: April 26, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Unstable
• ASCVD
• Chest Pain
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• NSTEMI
• STEMI
• Unstable Angina

Intervention

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.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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