Teaching: Individual to Increase Adherence to Therapeutic Regimen in Hypertension Arterial and/or Diabetes Type 2 (ENURSIN)
Primary Purpose
Diabetes Mellitus, Type 2, Hypertension
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Teaching: Individual (5606)
Sponsored by

About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Medication adherence, Patient compliance, Diabetes mellitus, Type 2, Hypertension, Nursing, Nursing process, Teaching, Randomized controlled trial
Eligibility Criteria
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.
Sites / Locations
- Empresa Social del Estado Instituto de Salud de Bucaramanga (ESE ISABU)
- Nursing School, Universidad Industrial de Santander
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Teaching: Individual (5606)
Usual care
Arm Description
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.
People will continue to receive usual care in the health center where they usually assist to medical controls.
Outcomes
Primary Outcome Measures
Changes of mean score adherence to treatment from baseline at 6 and 12 months
Measured by Treatment Behavior: Illness or Injury (1609)
Secondary Outcome Measures
Changes of mean score glycosylated hemoglobin from baseline at 6 and 12 months
Measured in peripheral venous blood
Changes of mean systolic blood pressure from baseline at 6 and 12 months
Measured by ambulatory blood pressure monitoring
Full Information
NCT ID
NCT02758275
First Posted
April 27, 2016
Last Updated
October 17, 2017
Sponsor
Universidad Industrial de Santander
Collaborators
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), Cardiecol, Instituto de Salud de Bucaramanga
1. Study Identification
Unique Protocol Identification Number
NCT02758275
Brief Title
Teaching: Individual to Increase Adherence to Therapeutic Regimen in Hypertension Arterial and/or Diabetes Type 2
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 28, 2016 (Actual)
Primary Completion Date
July 21, 2016 (Actual)
Study Completion Date
September 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Industrial de Santander
Collaborators
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), Cardiecol, Instituto de Salud de Bucaramanga
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Hypertension
Keywords
Medication adherence, Patient compliance, Diabetes mellitus, Type 2, Hypertension, Nursing, Nursing process, Teaching, Randomized controlled trial
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Teaching: Individual (5606)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
People will continue to receive usual care in the health center where they usually assist to medical controls.
Intervention Type
Behavioral
Intervention Name(s)
Teaching: Individual (5606)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes of mean score adherence to treatment from baseline at 6 and 12 months
Description
Measured by Treatment Behavior: Illness or Injury (1609)
Time Frame
6 and 12 months
Secondary Outcome Measure Information:
Title
Changes of mean score glycosylated hemoglobin from baseline at 6 and 12 months
Description
Measured in peripheral venous blood
Time Frame
6 and 12 months
Title
Changes of mean systolic blood pressure from baseline at 6 and 12 months
Description
Measured by ambulatory blood pressure monitoring
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Lucrecia SL Romero Guevara, MSc Nursing
Organizational Affiliation
Universidad Industrial de Santander
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dora Inés DI Parra, MSc Nursing
Organizational Affiliation
Universidad Industrial de Santander
Official's Role
Principal Investigator
Facility Information:
Facility Name
Empresa Social del Estado Instituto de Salud de Bucaramanga (ESE ISABU)
City
Bucaramanga
State/Province
Santander
ZIP/Postal Code
680001393
Country
Colombia
Facility Name
Nursing School, Universidad Industrial de Santander
City
Bucaramanga
State/Province
Santander
ZIP/Postal Code
680002212
Country
Colombia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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
Results Reference
result
Citation
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
Results Reference
result
PubMed Identifier
31171916
Citation
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.
Results Reference
derived
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Teaching: Individual to Increase Adherence to Therapeutic Regimen in Hypertension Arterial and/or Diabetes Type 2
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