The Use of Educational Technology in Improving Adherence Therapy

October 26, 2017 updated by: Grazia Maria Guerra, University of Sao Paulo General Hospital

HYPERTENSIVE PATIENT ADHERENCE TO TREATMENT: THE USE OF THERAPEUTIC COMMUNICATION ASSOCIATED WITH TECHNOLOGY EDUCATIONAL IN HEALTH PROMOTION"

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Behavioral: 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.
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
Experimental: 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
Behavioral: 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.
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
Experimental: 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
Behavioral: 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.
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
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
Other: 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,
No Intervention: No intervention
No type of intervention was performed making 2 nursing visits at baseline and 1 after 120 days (No intervention)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
measure blood arterial pressure
Time Frame: 4 months
At the first nurse interview (day 0: randomization), a questionnaire was used to obtain information related to general data, habits, history of disease, other risk factors for cardiovascular disease, and prescribed medications. This questionnaire was used only to characterize the adherence behavior and the risk factors at the beginning the study, but was not used to evaluate modifications of behavior during the study. Body weight and height were measured. Three consecutive measurements of BP were taken after the patient had rested for 5 min in the supine position.
4 months
Ambulatory Blood Pressure monitoring
Time Frame: 4 months
Ambulatory BP monitoring was recorded at day ) in randomization and 120 days of follow-up for 24 h with a noninvasive ABPM (Space Labs 90207 monitor; Space Labs, Redmond, WA) with an appropriate-sized cuff. The monitor was placed on the nondominant arm and was set to take BP readings every 10 min during the day and every 20 min at nigh
4 months
Pill count
Time Frame: up to 4 months
count of the compliments dispensed by the pharmacy and count of the empty blisters delivered in the consultation
up to 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The brief version of the World Health Organization quality of life (WHOQOL-BREF)
Time Frame: 4 months
Questinaire
4 months
The Duke University Religion Index (DUREL) for a brief measure of religiosity that can be included between religion and health outcomes.
Time Frame: 4 months
the isntrument
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Luiz Aparecido Bortolotto
Chao Lung Wen
Margarida Vieira
Miriam Harume Tsunemi
Isabela Ribeiro Braga Fistarol
Jefferson Carlos de Oliveira
Dante Marcelo Artiga Giorgi
Heno Ferreira Lopes
Fernanda Marciano Consolim-Colombo
Ivonete Sanches Giacometti Kowalski

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 17, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 08625112.7.0000.0068
  • 2012-50559-1 (Other Grant/Funding Number: FAPESP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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