Use the Back button in your browser to see the other results of your search or to select another record.
The women's heart health programme: a pilot trial of sex-specific cardiovascular management |
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 |
BMC Women's Health 2018 Apr 16;18(56):Epub |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND: There is increasing knowledge of sex-specific differences in cardiovascular disease and recognition of sex disparities in management. In our study, we investigated whether a cardiovascular programme tailored to the specific needs of women could lead to improved outcomes. METHODS: We randomised 100 female patients to receive cardiology follow-up with the conventional sex-neutral cardiac programme (control), or the sex-tailored women's heart health programme (intervention). The intervention group was managed by an all-women multidisciplinary team and received culture-centred health intervention workshops, designed through in-depth interviews with the participants. The primary outcome was cardiovascular risk factor improvement at 1 year. Secondary outcomes include cardiovascular event rates, quality of life scores, and self-reported improvement in knowledge, attitudes, intentions and practices. Generalised structural equation model analysis was used to determine if the intervention group had better outcomes at alpha level 0.1. RESULTS: The mean age was 67.3 +/- 12.7 years, with an ethnic distribution of 70% Chinese, 18% Malays, and 12% Indians. The majority of these patients had no formal or primary level of education (63%), and were mostly unemployed (78%). Patients in intervention group had better control of diabetes mellitus (lower HbA1c of 0.63% (CI 0.21 to 1.04), p = 0.015) and lower body-mass-index (0.74 kg/m2 (CI 0.02 to 1.46), p = 0.092) at 1 year, but there was no significant difference in blood pressure or lipid control. Overall, there was a trend towards better risk factor control, 31.6% of intervention group versus 26.5% of control group achieved improvement in at least 1 CV risk factor control to target range. There was no significant difference in incidence of cardiovascular events, quality of life, or domains in knowledge, attitudes, intention and practices. CONCLUSION: This pilot study is the first of its kind evaluating a new model of care for women with heart disease. The potential to improve outcomes needs to be studied in a larger trial with longer follow up. TRIAL REGISTRATION: This trial was prospectively registered ClinicalTrials.gov on 6 May 2013. Trial number 2013/00088. Identifier NCT02017470.
|