Affiliation:
1. Faculty of Nursing and Midwifery Shifa Tameer‐e‐Millat University Islamabad Pakistan
2. Department of Physiological Nursing, School of Nursing University of California San Francisco California USA
3. Department of Epidemiology & Biostatistics, School of Medicine University of California San Francisco California USA
4. The Office of Research, Innovation and Commercialization (ORIC) Shifa Tameer‐e‐Millat University Islamabad Pakistan
Abstract
AbstractBackgroundThis study aimed to test the efficacy of patient‐centered self‐management intervention (PACE‐SMI) to improve HbA1c, self‐efficacy, and self‐care behaviors in adults with type 2 diabetes mellitus (T2DM).MethodsIn this multicenter, parallel two‐arm randomized controlled trial, 612 adults with T2DM and HbA1c ≥ 7% were enrolled and assigned to the control group (n = 310) and the intervention group (n = 302) using stratified permuted block randomization. The control group received usual care, whereas the intervention group received usual care plus nurse‐led, theory‐driven, culturally tailored PACE‐SMI, comprising eight weekly sessions of individualized education, counseling, behavioral training, and home visit. Outcomes were assessed at baseline, postintervention, and 3 months follow‐up.ResultsData at 3 months were provided by 583 participants (control: n = 295, intervention: n = 288). Per‐protocol analysis showed that the intervention group had a lower mean HbA1c (8.49% [standard deviation (SD), 1.58]) than the control group (8.74% [SD, 1.62]), with small yet statistically significant mean difference of 0.25% (95% confidence interval [CI], −0.01 to 0.51; Cohen's d = 0.16; p = 0.03). Self‐efficacy and self‐care behaviors significantly improved in the intervention group (116.89 [SD, 25.50] and 70.01 [SD, 17.97]) compared to the control group (75.43 [SD, 18.99] and 51.54 [SD, 12.04]), with mean differences of 41.48 (95% CI, 37.83–45.13; Cohen's d = 1.84; p < 0.0001) and 18.56 (95% CI, 16.08–21.04; Cohen's d = 1.22; p < 0.0001), respectively. Linear regression analysis indicated the effect of PACE‐SMI on HbA1c was significantly mediated by improvements in self‐efficacy and self‐care behaviors (R2 = 0.232, p < 0.001).ConclusionPACE‐SMI led to modest but significant improvement in HbA1c and substantial enhancements in self‐efficacy and self‐care behaviors in adults with T2DM.image