Background

The rising burden of type 2 diabetes mellitus (DM) and its associated complications is affecting the functional capacity of the individuals, their quality of life and demand for healthcare services with significant economic impact on health care systems and the national economies. Given the enormous health and economic impact, preventing type 2 DM progression and reducing the risk of complications require immediate attention. Evidence from western countries suggests that self-management can slow the progression of type 2 DM and minimize the risk of major complications lowering health-care costs. Effective self-management, however, demands patients' confidence and their full commitment to perform self-care tasks necessitating a patient-centered approach. This study aims to test the efficacy of a patient-centered self-management intervention to improve glycemic control, self-efficacy and self-care behaviors in adults with type 2 DM.

Patients and methods

The study will be carried out as a parallel arm, randomized, controlled trial in four public tertiary care hospitals in Faisalabad, Pakistan. A total of 612 patients with type 2 DM will be recruited and randomly assigned to two groups: a control and an intervention group. The intervention group will receive a patient-centered self-management intervention for eight weeks duration. Subjects will be followed up for three months. The primary outcome will be glycemic control (HbA1c), and secondary outcome variables will include self-efficacy and self-care behaviors all measured at three points in time (baseline, at the end of intervention and at three months follow-up).

Discussion

This randomized controlled trial will provide critical information about the efficacy of patient-centered self-management intervention in improving HbA1c, self-efficacy and self-care behaviors. If successful, this evidence-based care intervention may be provided to all DM patients by updating hospital policies.

Trial registration

NIH: US National Library of Medicine clinicaltrials.gov Identifier: NCT05491252, Shifa Tameer e Millat University Protocol Record: 335-21. Registration date: August 08, 2022. Recruitment began: April 21, 2022. Recruitment completed: July 27, 2022. URL http://www.clinicaltrials.gov.

Background

Patient-centered care in diabetes self-management might be a significant factor in improving health outcomes of adults with type 2 diabetes, yet the supporting evidence is inadequate. This review aimed at assessing the effectiveness of patient-centered self-management care interventions on glycemic control (HbA1c) and self-care behaviors compared with usual care.

Methods

CINAHL, PubMed, Cochrane Library, Google Scholar, and the HEC Digital Library were searched for studies in English language that assessed patient-centered self-management educational and/or behavioral interventions in adults aged 18 years or older with type 2 diabetes from 2005 to 2020. Interventional studies with at least 3 months of follow-up and reporting on self-care outcomes such as glycemic control (HbA1c) and self-care behaviors including diet control, physical activity, foot care, and medication adherence were included.

Results

Of 168 identified records, 24 were found eligible comprising 20 RCTs and four QESs with total 4,083 participants. The meta-analysis involved 19 RCTs that provided enough information for a pooled estimate of HbA1c. Compared with the control group, patient-centered self-management interventions significantly lowered HbA1c, -0.56 (95% CI -0.79, -0.32). Stratified analysis for HbA1c with respect to various aspects of intervention showed larger effects in interventions employing both educational and behavioral components, -0.66 (95% CI -0.97, -0.34); spanned over shorter (<03 months) duration, -0.85 (95% CI -1.28, -0.43); administered by nurses, -0.80 (95% CI -1.44, -0.16); and delivered in community settings -0.70 (95% CI -1.14, -0.26).

Conclusion

This systematic review provided evidence supporting the effectiveness of patient-centered self-management care interventions in improving glycemic control and self-care behaviors in adults with type 2 diabetes and identified key features of intervention contributing toward success.

BACKGROUND: This 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). METHODS: In 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. RESULTS: Data 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; Cohens 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; Cohens d = 1.84; p < 0.0001) and 18.56 (95% CI, 16.08-21.04; Cohens 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). CONCLUSION: PACE-SMI led to modest but significant improvement in HbA1c and substantial enhancements in self-efficacy and self-care behaviors in adults with T2DM.