Teaching: Individual to Increase Adherence to Therapeutic Regimen in Hypertension Arterial and/or Diabetes Type 2

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Nursing Intervention Teaching: Individual to Increase Adherence to Therapeutic Regimen in People With Hypertension Arterial and/or Diabetes Mellitus Type 2

Conditions
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Diabetes Mellitus, Type 2, Hypertension

Intervention / Treatment
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* Behavioral: Teaching: Individual (5606)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teaching: Individual (5606)<br>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)<br>* Usual care and Teaching: Individual (5606): It consists of 6 educational sessions: Behavior Modification (4360) Promotion of a behavior change. Teaching Disease Process (5602) Assisting the patient to understand information related to a specific disease process. Teaching: Prescribed Medication (5616) Preparing a patient to safely take prescribed medications and monitor for their effects. Teaching: Prescribed Diet (5614) Preparing a patient to correctly follow a prescribed diet. Teaching: Prescribed Exercise (5612) Preparing a patient to achieve and/or maintain a prescribed level of activity. Coping Enhancement (5230) Assisting a patient to adapt to perceived stressors, changes, or threats that interfere with meeting life demands and roles.<br>|
| No Intervention: Usual care<br>People will continue to receive usual care in the health center where they usually assist to medical controls. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of mean score adherence to treatment from baseline at 6 and 12 months | Measured by Treatment Behavior: Illness or Injury (1609) | 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of mean score glycosylated hemoglobin from baseline at 6 and 12 months | Measured in peripheral venous blood | 6 and 12 months | 
| Changes of mean systolic blood pressure from baseline at 6 and 12 months | Measured by ambulatory blood pressure monitoring | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication adherence, Patient compliance, Diabetes mellitus, Type 2, Hypertension, Nursing, Nursing process, Teaching, Randomized controlled trial