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Completed

NCT Number: NCT02758275

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Empresa Social del Estado Instituto de Salud de Bucaramanga (ESE ISABU), Bucaramanga, Santander Department, Colombia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Teaching: Individual (5606)

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad Industrial de Santander

Other

Collaborators

  • Cardiecol
  • Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
  • Instituto de Salud de Bucaramanga

Registry information

Official study title

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

Acronym: ENURSIN

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
May 2, 2016
Registry last updated
Oct 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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