NCT02758275

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

April 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 2, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2017

Completed
Last Updated

October 19, 2017

Status Verified

October 1, 2017

Enrollment Period

3 months

First QC Date

April 27, 2016

Last Update Submit

October 17, 2017

Conditions

Diabetes Mellitus, Type 2Hypertension

Keywords

Medication adherencePatient complianceDiabetes mellitus, Type 2HypertensionNursingNursing processTeachingRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Changes of mean score glycosylated hemoglobin from baseline at 6 and 12 months

    6 and 12 months

  • Changes of mean systolic blood pressure from baseline at 6 and 12 months

    6 and 12 months

Study Arms (2)

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.

Behavioral: Teaching: Individual (5606)

Usual care

NO INTERVENTION

People will continue to receive usual care in the health center where they usually assist to medical controls.

Interventions

Teaching: Individual (5606)BEHAVIORAL

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.

Teaching: Individual (5606)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Empresa Social del Estado Instituto de Salud de Bucaramanga (ESE ISABU)

Bucaramanga, Santander Department, 680001393, Colombia

Location

Nursing School, Universidad Industrial de Santander

Bucaramanga, Santander Department, 680002212, Colombia

Location

Related Publications (3)

  • 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

    RESULT

  • 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.

    PMID: 31171916DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2HypertensionMedication AdherencePatient Compliance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse Research, MSc Nursing. Professor, School of Nursing. Universidad Industrial de Santander, Bucaramanga, Colombia.

Study Record Dates

First Submitted

April 27, 2016

First Posted

May 2, 2016

Study Start

April 28, 2016

Primary Completion

July 21, 2016

Study Completion

September 15, 2017

Last Updated

October 19, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

CO(2)