The Use of Educational Technology in Improving Adherence Therapy

NCT03324386 | Completed

• 2 other identifiers: 08625112.7.0000.00682012-50559-1
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Medication Nonadherence; Hypertension, Resistant to Conventional Therapy

Keywords

Hypertension; Tecnology; Nursing; Education

Outcome Measures

Primary Outcomes (3)

• 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.

  4 months

• 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

  4 months

• Pill count

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

  up to 4 months

Secondary Outcomes (2)

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

  4 months

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

  4 months

Study Arms (4)

Individual Orientation

EXPERIMENTAL

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

VLE for Distance Learning

EXPERIMENTAL

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

E-blended Learning

EXPERIMENTAL

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

Experimental: Individual Orientation 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.

E-blended Learning; Individual Orientation; VLE for Distance Learning

Experimental: VLE for Distance Learning 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

E-blended Learning; Individual Orientation

Experimental: E-blended Lerarning 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; VLE for Distance Learning

Conventional Therapy - Control Group OTHER

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

E-blended Learning

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have the medical diagnosis of arterial hypertension,
• 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),
• Must be able to swallow tablets and under drug treatment with antihypertensives,
• Have digital accessibility through smart phones, tablets or notebooks and PCs.

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Luiz Aparecido Bortolotto: collaborator
• Chao Lung Wen: collaborator
• Margarida Vieira: collaborator
• Miriam Harume Tsunemi: collaborator
• Isabela Ribeiro Braga Fistarol: collaborator
• Jefferson Carlos de Oliveira: collaborator
• Dante Marcelo Artiga Giorgi: collaborator
• Heno Ferreira Lopes: collaborator
• Fernanda Marciano Consolim-Colombo: collaborator
• Ivonete Sanches Giacometti Kowalski: collaborator

MeSH Terms

Conditions

Medication Adherence; Hypertension Resistant to Conventional Therapy; Hypertension

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Individual Orientation: receiving individual orientation required by an embracement strategy characterized by 7 nursing visits at 20-day intervals, for 4 months);
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: October 27, 2017
• Study Start: December 18, 2013
• Primary Completion: April 25, 2015
• Study Completion: February 17, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share