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NCT02758275 Clinical Trial

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

Hypertension Clinical Trial

— ENURSIN  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02758275
Other study ID # 1861
Secondary ID
Status Completed
Phase N/A
First received April 27, 2016
Last updated October 17, 2017
Start date April 28, 2016
Est. completion date September 15, 2017

Study information
Verified date October 2017
Source Universidad Industrial de Santander
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 200
Est. completion date September 15, 2017
Est. primary completion date July 21, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Teaching: Individual (5606)
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.

Locations
Country Name City State
Colombia Empresa Social del Estado Instituto de Salud de Bucaramanga (ESE ISABU) Bucaramanga Santander
Colombia Nursing School, Universidad Industrial de Santander Bucaramanga Santander

Sponsors (4)
Lead Sponsor Collaborator
Universidad Industrial de Santander Cardiecol, Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), Instituto de Salud de Bucaramanga

Country where clinical trial is conducted

Colombia, 

References & Publications (2)

López L, Romero S, Parra D, Rojas L. Adherence to treatment: concept and measurement. Hacia promoc. salud. 2016; 21(1): 117-137. DOI: 10.17151/hpsal.2016.21.1.10

Romero S, Parra D, Sánchez J, Rojas L. Adherence to therapeutic regimen of hypertension andtype-2 diabetes patients in Bucaramanga, Colombia . Rev Univ Ind Santander Salud. 2017; 49(1): 37-44. DOI: http://dx.doi.org/10.18273/revsal.v49n1-2017004

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Changes of mean score glycosylated hemoglobin from baseline at 6 and 12 months Measured in peripheral venous blood 6 and 12 months
Secondary Changes of mean systolic blood pressure from baseline at 6 and 12 months Measured by ambulatory blood pressure monitoring 6 and 12 months
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