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

NCT ID: NCT02758275

Last Updated: 2017-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-28

Study Completion Date

2017-09-15

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2 Hypertension

Keywords

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Medication adherence Patient compliance Diabetes mellitus, Type 2 Hypertension Nursing Nursing process Teaching Randomized controlled trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Teaching: Individual (5606)

Intervention Type 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.

Usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

OTHER_GOV

Sponsor Role collaborator

Cardiecol

UNKNOWN

Sponsor Role collaborator

Instituto de Salud de Bucaramanga

OTHER

Sponsor Role collaborator

Universidad Industrial de Santander

OTHER

Sponsor Role lead

Responsible Party

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Sandra Lucrecia Romero Guevara

Nurse Research, MSc Nursing. Professor, School of Nursing. Universidad Industrial de Santander, Bucaramanga, Colombia.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sandra Lucrecia SL Romero Guevara, MSc Nursing

Role: PRINCIPAL_INVESTIGATOR

Universidad Industrial de Santander

Dora Inés DI Parra, MSc Nursing

Role: PRINCIPAL_INVESTIGATOR

Universidad Industrial de Santander

Locations

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

Bucaramanga, Santander Department, Colombia

Site Status

Nursing School, Universidad Industrial de Santander

Bucaramanga, Santander Department, Colombia

Site Status

Countries

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Colombia

References

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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

Reference Type 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

Reference Type 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.

Reference Type DERIVED
PMID: 31171916 (View on PubMed)

Other Identifiers

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1861

Identifier Type: -

Identifier Source: org_study_id