"Teaching: Individual" to increase adherence to therapeutic regimen in people with hypertension and type-2 diabetes: protocol of the controlled clinical trial ENURSIN.

BACKGROUND: Worldwide, hypertension affects approximately 25% of the adult population and diabetes about 8.5%. Lack of adherence to prescribed treatment regimen remains a problem among patients undergoing long-term treatment, showing high non-adherence rates, at estimated range of between 36 and 93%. In our city, patients with hypertension and diabetes in primary care are looked after mainly by doctors with little nursing support; also, there is no published dataset among Colombian populations on the effect of nursing intervention to increase adherence to therapeutic regimen. The aim of this study was to evaluate the efficacy of nursing intervention “Teaching: Individual” compared with usual care, to increase adherence to therapeutic regimen in people with hypertension and/or type-2 diabetes, and to analyze the impact to glycosylated hemoglobin and systolic blood pressure levels. METHODS: A two-arm, single-blinded, randomized controlled trial, with participants allocated to either intervention group with “Teaching: Individual” provided by two nurses, or control group receiving routine care only. Two Hundred patients attending cardiovascular risk programs of Bucaramanga, Colombia were included. Nursing intervention consisted of six educational sessions about Coping Enhancement; Behavior Modification; Teaching: Disease Process, Prescribed Medication, Prescribed Diet and Prescribed Exercise. The outcomes were Treatment Behavior: Illness or Injury (adherence to treatment), levels of both glycosylated hemoglobin (HbA1c) and systolic blood pressure for 24 h, to be measured at baseline and two follow-up time points. Basic characteristics of the groups were compared through chi-square/Fisher’s exact or Students-T/Mann-Whitney U test. Outcomes were evaluated with repeated data methods and investigated changes in the outcomes over time and to compare these changes among treatment groups, and statistical significance with p-value < 0.05 were considered. DISCUSSION: The nursing intervention “Teaching: Individual” to increase adherence to therapeutic regimen in people with hypertension and/or type-2 diabetes represents an innovative care approach intended for low-income population. The study will advise district health system policy makers and managers as to the efficacy of implementing this intervention. Should this intervention turn out efficacious, it can potentially achieve wide application in cardiovascular risk programs. TRIAL REGISTRATION: ENURSIN was registered in ClinicalTrials.gov (NCT02758275) on April 27, 2016, protocol number 01.