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The Use of Educational Technology in Improving Adherence Therapy

NCT ID: NCT03324386

Last Updated: 2017-10-27

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

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-18

Study Completion Date

2017-02-17

Brief Summary

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Few studies show the benefits of educational technologies a support for the control of chronic diseases. The approach known as 'embracement' adopts relational strategies or soft technologies which promote bonding and may impact therapy adherence and quality of life in hypertensive patients.Objectives:To assess the impact of the embracement approach on therapy adherence, quality of life, and the white coat effect in hypertensive outpatients followed in a specialized clinic. This approach may be associated or not with the use of educational technology in a virtual learning environment(VLE) for distance learning (DL) and with use the educational technology in Blended E-learning (E-BLENDED)

Detailed Description

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Hypertension (HBP) is an important risk factor for cardiovascular disease and has become a common public health problem world wide due to increased longevity. The challenge for next decades is to improve the adherence of patients with chronic degenerative diseases. It is detected that hypertension has been considered a risk factor for determining the incidence of cardiovascular diseases, which directs it to the high cost of treatment in Brazilian public health, therefore the prevention of impairment to health is a priority. Many patients with hypertension do not make the required behavioral changes in your lifestyle, do not forget to take medications or taking medication to fulfil the effective control of the disease. The present study aims to assess the impact of a health promotion program using the Therapeutic Communication and Educational Technology associated of the telemedicine (E-Care of Hypertension) in the performance improvement of patient adherence to treatment. This study aims to evaluation the impact of health promotion program on therapeutic compliance in hypertensive patients, of difficult control of blood pressure levels, with individual guidance through nursing consultation every 20 days, using the approach of "Therapeutic Communication" associated "Educational Technology" for a period of 120 days. For this study will be conducted with 60 patients randomly divided into four groups, according to the care of new cases registered in Ambulatory Hypertension Unit of Heart Institute at Medical School of São Paulo University. The sample will be selected for convenience in accordance with the established day of the week depending on availability of researchers and patients' consent. This approach may be associated or not with the use of educational technology in a virtual learning environment (VLE) for distance learning (DL).This was a prospective randomized clinical study conducted with the following 4 groups of hypertensive patients: This was a prospective randomized clinical study conducted with the following 4 groups of hypertensive patients: Embracement: Group receiving individual orientation required by an embracement strategy characterized by 7 nursing visits at 20-day intervals, for 4 months; Group VLE using a technological education strategy (E-Care of Hypertension) for distance learning (DL) and making 7 nursing visits at 20-day intervals, for 4 months; Control Group that performed 1 nursing visit at baseline and 1 after 120 days.). Group E-blended learning using a technological education strategy (E-Care of Hypertension) which is evaluating the influence of the use of educational technology associated with face-to-face consultation with the health professional (Blended E-learning) and making 7 nursing visits at 20-day intervals, for 4 months. At baseline and after 120 days, the following tools were applied: The Spielberger State-Trait Anxiety Inventory (STAI), the Morisky test, WHOQOL, and ambulatory blood pressure monitoring (ABPM). The VLE group had remote access to the "E-Care of Hypertension" site (6 specific educational modules).The E-BLENDED Group had acess to "E-Care of Hypertension" site (6 specific educational modules) with the presence of the nurse.

Conditions

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Medication Nonadherence Hypertension, Resistant to Conventional Therapy

Keywords

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Hypertension Tecnology Nursing Education

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

VLE Group use the technology in a virtual learning environment(VLE) for distance learning (DL), HYBRID Group use the educational technology in the E-blended mode leraning, A Group he use of embracement strategy (relational strategies).
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Individual Orientation: receiving individual orientation required by an embracement strategy characterized by 7 nursing visits at 20-day intervals, for 4 months);

Study Groups

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Individual Orientation

This was a prospective randomized clinical study conducted with the following 4 groups of hypertensive patients: Experimental: individual orientation: receiving individual orientation required by an embracement strategy characterized by 7 nursing visits at 20-day intervals, for 4 months);The ntervention is composed by relational strategies characterized by interpersonal relationships

Group Type EXPERIMENTAL

Experimental: Individual Orientation

Intervention Type BEHAVIORAL

This approach may be individual orientation with by an embracement strategy (relational strategies) may be making 7 nursing visits at 20-day intervals, for 4 month.

Experimental: VLE for Distance Learning

Intervention Type BEHAVIORAL

Experimental: This approach may be associated with the use of educational technology (E-Care of Hypertension) in a virtual learning environment(VLE) for distance learning (DL) consultation with the health professional and making 7 nursing visits at 20-day intervals, for 4 months

VLE for Distance Learning

This was a prospective randomized clinical study conducted with the following 4 groups of hypertensive patients:Experimental: a technological education strategy for distance learning (DL), using a technological education strategy (E-Care of Hypertension) for Distance Learning (DL) characterized by 7 nursing visits at 20-day intervals, for 4 months). The intervention is composed by the use of equipment-oriented techniques or audio-visual aids in educational environments remotely accessed for health education specifically for hypertensive patients

Group Type EXPERIMENTAL

Experimental: Individual Orientation

Intervention Type BEHAVIORAL

This approach may be individual orientation with by an embracement strategy (relational strategies) may be making 7 nursing visits at 20-day intervals, for 4 month.

Experimental: E-blended Lerarning

Intervention Type BEHAVIORAL

This approach may be associated with the use of educational technology (E-Care of Hypertension) in the blended e-learning mode associated with face-to-face with the health professional and making 7 nursing visits at 20-day intervals, for 4 months

E-blended Learning

This was a prospective randomized clinical study with the patient received experimental intervention: a technological education strategy with E-blended Learning modality with E-Care of Hypertension, associated with face-to-face consultation with the health professional and making 7 nursing visits at 20-day intervals, for 4 months. The intervention is composed by the use of equipment-oriented techniques or audio-visual aids in presential educational environments intended for health education specifically for hypertensive patients

Group Type EXPERIMENTAL

Experimental: Individual Orientation

Intervention Type BEHAVIORAL

This approach may be individual orientation with by an embracement strategy (relational strategies) may be making 7 nursing visits at 20-day intervals, for 4 month.

Experimental: VLE for Distance Learning

Intervention Type BEHAVIORAL

Experimental: This approach may be associated with the use of educational technology (E-Care of Hypertension) in a virtual learning environment(VLE) for distance learning (DL) consultation with the health professional and making 7 nursing visits at 20-day intervals, for 4 months

Experimental: E-blended Lerarning

Intervention Type BEHAVIORAL

This approach may be associated with the use of educational technology (E-Care of Hypertension) in the blended e-learning mode associated with face-to-face with the health professional and making 7 nursing visits at 20-day intervals, for 4 months

Conventional Therapy - Control Group

Intervention Type OTHER

This approach may be individual orientation with conventional therapy may be making 2 nursing visits at baseline and 1 after 120 days,

No intervention

No type of intervention was performed making 2 nursing visits at baseline and 1 after 120 days (No intervention)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Experimental: Individual Orientation

This approach may be individual orientation with by an embracement strategy (relational strategies) may be making 7 nursing visits at 20-day intervals, for 4 month.

Intervention Type BEHAVIORAL

Experimental: VLE for Distance Learning

Experimental: This approach may be associated with the use of educational technology (E-Care of Hypertension) in a virtual learning environment(VLE) for distance learning (DL) consultation with the health professional and making 7 nursing visits at 20-day intervals, for 4 months

Intervention Type BEHAVIORAL

Experimental: E-blended Lerarning

This approach may be associated with the use of educational technology (E-Care of Hypertension) in the blended e-learning mode associated with face-to-face with the health professional and making 7 nursing visits at 20-day intervals, for 4 months

Intervention Type BEHAVIORAL

Conventional Therapy - Control Group

This approach may be individual orientation with conventional therapy may be making 2 nursing visits at baseline and 1 after 120 days,

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Have the medical diagnosis of arterial hypertension,
2. Have blood pressure levels equal or above 140 mmHg for systolic blood pressure (SBP), and equal or above 90 mmHg for diastolic blood pressure (DBP),
3. Must be able to swallow tablets and under drug treatment with antihypertensives,
4. Have digital accessibility through smart phones, tablets or notebooks and PCs.

Exclusion Criteria

1. Patients with important cognitive impairment will be considered excluded, that is, with poor understanding of simple questions,
2. Clinical diagnosis of Alzheimer's disease, or chorea diseases that lead to cognitive impairment such as senile dementia,
3. Diagnosis of insulin dependent diabetes. -
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luiz Aparecido Bortolotto

UNKNOWN

Sponsor Role collaborator

Chao Lung Wen

UNKNOWN

Sponsor Role collaborator

Margarida Vieira

UNKNOWN

Sponsor Role collaborator

Miriam Harume Tsunemi

UNKNOWN

Sponsor Role collaborator

Isabela Ribeiro Braga Fistarol

UNKNOWN

Sponsor Role collaborator

Jefferson Carlos de Oliveira

UNKNOWN

Sponsor Role collaborator

Dante Marcelo Artiga Giorgi

UNKNOWN

Sponsor Role collaborator

Heno Ferreira Lopes

UNKNOWN

Sponsor Role collaborator

Fernanda Marciano Consolim-Colombo

UNKNOWN

Sponsor Role collaborator

Ivonete Sanches Giacometti Kowalski

UNKNOWN

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Grazia Maria Guerra

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2012-50559-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

08625112.7.0000.0068

Identifier Type: -

Identifier Source: org_study_id