Teaching: Individual to Increase Adherence to Therapeutic Regimen in Hypertension Arterial and/or Diabetes Type 2
- Conditions
- Diabetes Mellitus, Type 2Hypertension
- Registration Number
- NCT02758275
- Lead Sponsor
- Universidad Industrial de Santander
- Brief Summary
The purpose of this study is to improve the adherence of therapeutic regimen in people with hypertension arterial and/or diabetes mellitus type 2. Our hypothesis is the nursing intervention "Teaching: Individual", is more effective to increase adherence of therapeutic regimen in people with hypertension arterial and/or diabetes mellitus type 2, than usual care.
- Detailed Description
Introduction: The hypertension arterial and diabetes mellitus are chronic diseases with a high burden of disease. It affects approximately 25% of the adult population worldwide and is an important risk factors for global mortality. As for the diabetes, worldwide there are about 346 million people with diabetes and 80% of them live in countries with low and middle income. The recommendations for treating of these diseases includes the pharmacological treatment and modification of lifestyle: salt restriction, moderation in alcohol consumption, high consumption of fruits and vegetables, low-fat diet, weight reduction and regular physical activity. The adherence to these guidelines are essential keys to success in handling these pathologies. The lack of adherence to the prescribed treatment regimen remains a problem among patients with long-term treatment.
Objective: To evaluated the efficacy of nursing intervention "Teaching: Individual" compared with usual care, to increase adherence of therapeutic regimen in people with hypertension arterial and/or diabetes mellitus type 2.
Methods: Randomized controlled trial. 200 patients with hypertension arterial and/or diabetes mellitus type 2 attending cardiovascular risk programs of Bucaramanga, Colombia will include . Nursing intervention to evaluate is "Teaching: Individual" consisting in six educational sessions. The investigators will measure 0, 6 y 12 months: Treatment Behavior: Illness or Injury (1609) (adherence treatment), glycosylated hemoglobin (HbA1c) and systolic blood pressure for 24 hours. Base characteristics of the groups will be compare through chi-square/Fisher´s exact or Students-T/Mann-Whitney U test. Outcomes will be evaluate by paired T-tests or Wilcoxon test at different follow-up times and statistical significance with p-value \< 0.05 will considered.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Adult population ≥ 18 years old
- Medical diagnosis of hypertension arterial and/or diabetes mellitus type 2.
- Attendees cardiovascular risk programs of Empresa Social del Estado Instituto de Salud de Bucaramanga (ISABU)
- People totally independent of their care.
- Access to a fixed telephone line or mobile itself
- Be residents of Bucaramanga
- Changes in the mental sphere. Abbreviated Mental Test (Minimental) and Yesavage depression test.
- Communication limitations or chronic or serious alterations that make it hard compression of interventions.
- Subjects who are participating in a research study currently or during the last six months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Changes of mean score adherence to treatment from baseline at 6 and 12 months 6 and 12 months Measured by Treatment Behavior: Illness or Injury (1609)
- Secondary Outcome Measures
Name Time Method Changes of mean systolic blood pressure from baseline at 6 and 12 months 6 and 12 months Measured by ambulatory blood pressure monitoring
Changes of mean score glycosylated hemoglobin from baseline at 6 and 12 months 6 and 12 months Measured in peripheral venous blood
Trial Locations
- Locations (2)
Nursing School, Universidad Industrial de Santander
🇨🇴Bucaramanga, Santander, Colombia
Empresa Social del Estado Instituto de Salud de Bucaramanga (ESE ISABU)
🇨🇴Bucaramanga, Santander, Colombia