An interventional study of Teaching: Individual (5606) in Diabetes Mellitus, Type 2 and Hypertension, sponsored by Universidad Industrial de Santander. Completed at 2 sites in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-19.
Sponsored by Universidad Industrial de Santander · Not applicable, Interventional, and Supportive care
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.
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.
Exclusion Criteria:
People will receive an education session per month for a period of six months with an average duration of 30 minutes. These will be performed by nurses outside the collection of phase base line and follow-up measurements, previously trained for the purpose.
Behavioral: Teaching: Individual (5606)
People will continue to receive usual care in the health center where they usually assist to medical controls.
Usual care and Teaching: Individual (5606): It consists of 6 educational sessions: 1. Behavior Modification (4360) Promotion of a behavior change. 2. Teaching Disease Process (5602) Assisting the patient to understand information related to a specific disease process. 3. Teaching: Prescribed Medication (5616) Preparing a patient to safely take prescribed medications and monitor for their effects. 4. Teaching: Prescribed Diet (5614) Preparing a patient to correctly follow a prescribed diet. 5. Teaching: Prescribed Exercise (5612) Preparing a patient to achieve and/or maintain a prescribed level of activity. 6. Coping Enhancement (5230) Assisting a patient to adapt to perceived stressors, changes, or threats that interfere with meeting life demands and roles.
Changes of mean score adherence to treatment from baseline at 6 and 12 months
Measured by Treatment Behavior: Illness or Injury (1609)
Time frame: 6 and 12 months
Changes of mean score glycosylated hemoglobin from baseline at 6 and 12 months
Measured in peripheral venous blood
Time frame: 6 and 12 months
Changes of mean systolic blood pressure from baseline at 6 and 12 months
Measured by ambulatory blood pressure monitoring
Time frame: 6 and 12 months
Plan to share: No
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Universidad Industrial de Santander