Clinical trial NCT02758275: Teaching: Individual to Increase Adherence to Therapeutic Regimen in Hypertension Arterial and/or Diabetes Type 2
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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Hypertension
Keywords: Medication adherence
Patient compliance
Diabetes mellitus, Type 2
Hypertension
Nursing
Nursing process
Teaching
Randomized controlled trial
Lead sponsor: Universidad Industrial de Santander
Sponsor class: OTHER
Collaborators: name: Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
name: Cardiecol
name: Instituto de Salud de Bucaramanga
First posted: 2016-05-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Changes of mean score adherence to treatment from baseline at 6 and 12 months
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Changes of mean score glycosylated hemoglobin from baseline at 6 and 12 months
timeFrame: 6 and 12 months
measure: Changes of mean systolic blood pressure from baseline at 6 and 12 months
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Bucaramanga
country: Colombia
facility: Empresa Social del Estado Instituto de Salud de Bucaramanga (ESE ISABU)
state: Santander
city: Bucaramanga
country: Colombia
facility: Nursing School, Universidad Industrial de Santander
state: Santander
Study officials:
affiliation: Universidad Industrial de Santander
name: Sandra Lucrecia SL Romero Guevara, MSc Nursing
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Industrial de Santander
name: Dora Inés DI Parra, MSc Nursing
role: PRINCIPAL_INVESTIGATOR
References:
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
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
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.