A Culture-Centered Approach to Promoting Women's Heart Health in Singapore

NCT02017470 | Unknown

• 1 other identifier: DSRB:2013/00088
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This research focuses on health needs, constructed meanings of health, and meaningful health promotion tactics among women who are heart disease patients. Women with heart disease are considered as a highly vulnerable group for cardiovascular disease-related deaths in Singapore. Because the culture-centered approach has previously demonstrated that community-driven participatory processes of the Culture-Centered Approach (CCA) foster positive changes in health outcomes, this project highlights involvement of community members in developing effective health promotion regarding heart health. Rather than relying solely on interventions created by outside experts, The investigators aim to engage in Heart Health promotion that is meaningful through the involvement of these community members in processes of change. Thus, the investigators seek to engage these women who are heart disease patients in developing a heart health intervention that is beneficial to them. Through in-depth interviews, focus groups, the formation of advisory boards, and community-wide dialogue workshops led by these women, the investigators seek to identify specific heart health promoting strategies and tactics that are meaningful to the lived experiences of the women. As part of the overall solution, this project will work alongside the Women's Heart Health Clinic to create training materials and disseminate findings based on our analysis. Methodology: As far as the methodology, the investigators are using the Culture-Centered Approach (CCA) as well as using biomedical measures for evaluation. First, an advisory board will be formed to inform each step of our methodology and data analysis. First, the investigators will randomize one group of patients into the control group and one group into the experimental group. The investigators will conduct baseline measures for both groups. For the control group, the investigators will measure biomedical data at 3 times (3 months, 6 months, and 12 months). For the experimental group, the investigators will create advisory board that will consist of approx. 4 physicians and 6 patients. In-depth interviews will be conducted with women who have experienced CVD and who live in Singapore. Each interview will last a maximum of 90 minutes. Interviewees will be asked questions about how they understand health, their health experiences, and the obstacles they face in accessing health care in Singapore. Data from the interviews will be analyzed with the advisory board and will be used to guide discussion for the focus groups of women in the experimental group. Focus group sessions, each lasting a maximum of 90 minutes, will be conducted with the patients in the experimental group. In each session, the participants will collectively develop potential solutions for the issues that emerged during the earlier interviews.During the one-year period of study, a participant in the experimental group can participate in one or many of the one-on-one interviews, focus groups, or other activities planned based on the feedback of the participants. Based on the information given in the interviews, advisory board meetings, and focus groups, an intervention will be designed and carried out for the experimental group. This group will also be evaluated at 3 time points (3 months, 6 months, and 12 months) in addition to baseline.

Conditions

Cardiovascular Disease

Keywords

Women Heart Health; Cardiovascular Disease; focus group; advisory board; one-on-one interview

Outcome Measures

Primary Outcomes (1)

• Change in cardiovascular risk markers

  lipids, fasting glucose, Hba1C, body-mass-index and blood pressure

  12 months

Secondary Outcomes (3)

• Changes in quality of life

  12 months

• Changes in depression and activity status

  12 months

• Changes in cardiac overload and highly sensitive C reactive protein

  12 months

Study Arms (2)

Gender-tailored women's heart health outpatient programme

EXPERIMENTAL

The programme consists of general cardiologist, advanced practice nurse, dietician, physiotherapist and occupational therapist. The participant will be asked to participate in one-on-one interviewing, focus group discussions, and the forthcoming health promotion strategies that are developed based on the data collected

Other: Gender-tailored women's heart health outpatient programme

Conventional general cardiology outpatient programme

NO INTERVENTION

Interventions

Gender-tailored women's heart health outpatient programme OTHER

Gender-tailored women's heart health outpatient programme

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women aged \>21
• consecutive women admitted to NUH for general cardiology problems
• women patients attending general cardiology clinics

You may not qualify if:

• male patients
• Women requiring sub-specialty care (eg valve clinic, pulmonary hypertension clinic, congenital heart clinic)

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator

Study Sites (1)

National University Heart Centre, Singapore

Singapore, Singapore

Location

Related Publications (1)

• Low TT, Chan SP, Wai SH, Ang Z, Kyu K, Lee KY, Ching A, Comer S, Tan NQP, Thong EGHE, Nang T, Dutta M, Lam CSP. The women's heart health programme: a pilot trial of sex-specific cardiovascular management. BMC Womens Health. 2018 Apr 16;18(1):56. doi: 10.1186/s12905-018-0548-6.

  PMID: 29661196 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Low Ting Ting

  National University Heart Centre, Singapore

  PRINCIPAL INVESTIGATOR

• Mohan Jyoti Dutta

  Center for Culture-Centered Approach to Research and Evaluation

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: December 20, 2013
• Study Start: September 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 21, 2014

Record last verified: 2014-11

Locations

SG (1)