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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by National University Hospital, Singapore
Sponsor:
Collaborator:
National University, Singapore
Information provided by (Responsible Party):
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT02017470
First received: October 25, 2013
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Other: Gender-tailored women's heart health outpatient programme

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Culture-Centered Approach to Promoting Women's Heart Health in Singapore

Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Change in cardiovascular risk markers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    lipids, fasting glucose, Hba1C, body-mass-index and blood pressure


Secondary Outcome Measures:
  • Changes in quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes in depression and activity status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes in cardiac overload and highly sensitive C reactive protein [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gender-tailored women's heart health outpatient programme
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
No Intervention: Conventional general cardiology outpatient programme

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. women aged >21
  2. consecutive women admitted to NUH for general cardiology problems
  3. women patients attending general cardiology clinics

Exclusion Criteria:

  1. male patients
  2. Women requiring sub-specialty care (eg valve clinic, pulmonary hypertension clinic, congenital heart clinic)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02017470

Contacts
Contact: Carolyn Lam Su Ping carolyn_lam@nuhs.edu.sg

Locations
Singapore
National University Heart Centre, Singapore Recruiting
Singapore, Singapore
Contact: Low Ting Ting       ting_ting_low@nuhs.edu.sg   
Principal Investigator: Low Ting Ting         
Principal Investigator: Mohan Jyoti Dutta         
Sponsors and Collaborators
National University Hospital, Singapore
National University, Singapore
Investigators
Principal Investigator: Low Ting Ting National University Heart Centre, Singapore
Principal Investigator: Mohan Jyoti Dutta Center for Culture-Centered Approach to Research and Evaluation
  More Information

No publications provided

Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT02017470     History of Changes
Other Study ID Numbers: DSRB:2013/00088
Study First Received: October 25, 2013
Last Updated: December 16, 2013
Health Authority: Singapore: Health Sciences Authority

Keywords provided by National University Hospital, Singapore:
Women Heart Health
Cardiovascular Disease
focus group
advisory board
one-on-one interview

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014