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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
Sponsor:
Collaborators:
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Cardiecol
Instituto de Salud de Bucaramanga
Information provided by (Responsible Party):
Sandra Lucrecia Romero Guevara, Universidad Industrial de Santander

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Hypertension Behavioral: Teaching: Individual (5606) Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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:

  1. Behavior Modification (4360) Promotion of a behavior change.
  2. Teaching Disease Process (5602) Assisting the patient to understand information related to a specific disease process.
  3. Teaching: Prescribed Medication (5616) Preparing a patient to safely take prescribed medications and monitor for their effects.
  4. Teaching: Prescribed Diet (5614) Preparing a patient to correctly follow a prescribed diet.
  5. Teaching: Prescribed Exercise (5612) Preparing a patient to achieve and/or maintain a prescribed level of activity.
  6. Coping Enhancement (5230) Assisting a patient to adapt to perceived stressors, changes, or threats that interfere with meeting life demands and roles.
No Intervention: Usual care
People will continue to receive usual care in the health center where they usually assist to medical controls.


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Changes of mean score glycosylated hemoglobin from baseline at 6 and 12 months [ Time Frame: 6 and 12 months ]
    Measured in peripheral venous blood

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Colombia
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
Sponsors and Collaborators
Universidad Industrial de Santander
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Cardiecol
Instituto de Salud de Bucaramanga
Investigators
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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
More Information
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Additional Information:

Publications of Results:
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
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sandra Lucrecia Romero Guevara, Nurse Research, MSc Nursing. Professor, School of Nursing. Universidad Industrial de Santander, Bucaramanga, Colombia., Universidad Industrial de Santander
ClinicalTrials.gov Identifier: NCT02758275    
Other Study ID Numbers: 1861
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sandra Lucrecia Romero Guevara, Universidad Industrial de Santander:
Medication adherence
Patient compliance
Diabetes mellitus, Type 2
Hypertension
 Nursing
Nursing process
Teaching
Randomized controlled trial
Additional relevant MeSH terms:
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Hypertension
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases