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| Name | Class |
|---|---|
| Instituto Colombiano para el Desarrollo de la Ciencia y la TecnologÃa (COLCIENCIAS) | OTHER_GOV |
| Cardiecol | UNKNOWN |
| Instituto de Salud de Bucaramanga | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teaching: Individual (5606) | Experimental | 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. |
|
| Usual care | No Intervention | People will continue to receive usual care in the health center where they usually assist to medical controls. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teaching: Individual (5606) | Behavioral | Usual care and Teaching: Individual (5606): It consists of 6 educational sessions:
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Lucrecia SL Romero Guevara, MSc Nursing | Universidad Industrial de Santander | Principal Investigator |
| Dora Inés DI Parra, MSc Nursing | Universidad Industrial de Santander | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Empresa Social del Estado Instituto de Salud de Bucaramanga (ESE ISABU) | Bucaramanga | Santander Department | 680001393 | Colombia | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 | ||
| Result | 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 | ||
| 31171916 | Derived | Romero Guevara SL, Parra DI, Rojas LZ. "Teaching: Individual" to increase adherence to therapeutic regimen in people with hypertension and type-2 diabetes: protocol of the controlled clinical trial ENURSIN. BMC Nurs. 2019 Jun 4;18:22. doi: 10.1186/s12912-019-0344-0. eCollection 2019. |
| Label | URL |
|---|---|
| CARDIECOL program | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
Measured by ambulatory blood pressure monitoring
| 6 and 12 months |
| Nursing School, Universidad Industrial de Santander |
| Bucaramanga |
| Santander Department |
| 680002212 |
| Colombia |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |