Teaching: Individual to Increase Adherence to Therapeutic Regimen in Hypertension Arterial and/or Diabetes Type 2 (ENURSIN)
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|ClinicalTrials.gov Identifier: NCT02758275|
Recruitment Status : Completed
First Posted : May 2, 2016
Last Update Posted : October 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 Hypertension||Behavioral: Teaching: Individual (5606)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|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|
|Actual Study Start Date :||April 28, 2016|
|Actual Primary Completion Date :||July 21, 2016|
|Actual Study Completion Date :||September 15, 2017|
Experimental: Teaching: Individual (5606)
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)
Usual care and Teaching: Individual (5606): It consists of 6 educational sessions:
No Intervention: Usual care
People will continue to receive usual care in the health center where they usually assist to medical controls.
- Changes of mean score adherence to treatment from baseline at 6 and 12 months [ Time Frame: 6 and 12 months ]Measured by Treatment Behavior: Illness or Injury (1609)
- Changes of mean score glycosylated hemoglobin from baseline at 6 and 12 months [ Time Frame: 6 and 12 months ]Measured in peripheral venous blood
- Changes of mean systolic blood pressure from baseline at 6 and 12 months [ Time Frame: 6 and 12 months ]Measured by ambulatory blood pressure monitoring
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758275
|Empresa Social del Estado Instituto de Salud de Bucaramanga (ESE ISABU)|
|Bucaramanga, Santander, Colombia, 680001393|
|Nursing School, Universidad Industrial de Santander|
|Bucaramanga, Santander, Colombia, 680002212|
|Principal Investigator:||Sandra Lucrecia SL Romero Guevara, MSc Nursing||Universidad Industrial de Santander|
|Principal Investigator:||Dora Inés DI Parra, MSc Nursing||Universidad Industrial de Santander|