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CompletedNCT03324386Updated Oct 27, 2017

The Use of Educational Technology in Improving Adherence Therapy

An interventional study of Experimental: Individual Orientation and Experimental: VLE for Distance Learning in Medication Nonadherence and Hypertension, Resistant to Conventional Therapy, sponsored by University of Sao Paulo General Hospital. Completed. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-10-27.

Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 3 years 5 months after the study started (first participant enrolled Dec 2013, registered Jun 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
57
Allocation
Non-randomized
Ages
20 Years to 65 Years
Sex
All
01

Study summary

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)

Read the 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.

02

Conditions studied

  • Medication Nonadherence
  • Hypertension, Resistant to Conventional Therapy

Keywords

  • Hypertension
  • Tecnology
  • Nursing
  • Education
03

In context

Medication Adherence

937 studies on the registry are indexed under Medication Adherence; 159 are open to participants now.

This study's enrollment of 57 is below the median of 120 across 768 interventional studies indexed under Medication Adherence.

Browse Medication Adherence studies →

Lead sponsor

University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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. -
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Single group
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
57 participants (actual)

Study arms

  • 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 · Behavioral: Experimental: VLE for Distance Learning

  • 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 · Behavioral: Experimental: E-blended Lerarning

  • 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 · Behavioral: Experimental: VLE for Distance Learning · Behavioral: Experimental: E-blended Lerarning · Other: Conventional Therapy - Control Group

  • No intervention
    No intervention

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

Interventions

  • BehavioralExperimental: 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.

  • BehavioralExperimental: 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

  • BehavioralExperimental: 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

  • OtherConventional 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,

06

What researchers measure

Primary outcomes

  1. measure blood arterial pressure

    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.

    Time frame: 4 months

  2. Ambulatory Blood Pressure monitoring

    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

    Time frame: 4 months

  3. Pill count

    count of the compliments dispensed by the pharmacy and count of the empty blisters delivered in the consultation

    Time frame: up to 4 months

Secondary outcomes

  1. The brief version of the World Health Organization quality of life (WHOQOL-BREF)

    Questinaire

    Time frame: 4 months

  2. The Duke University Religion Index (DUREL) for a brief measure of religiosity that can be included between religion and health outcomes.

    the isntrument

    Time frame: 4 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03324386
Collaborators
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
Responsible party
Grazia Maria Guerra (Principal Investigator, InCor Heart Institute) — Principal investigator
First posted
Oct 27, 2017
Start date
Dec 18, 2013
Primary completion
Apr 25, 2015
Completion
Feb 17, 2017
Last update
Oct 27, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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