Clinical trial NCT03324386: The Use of Educational Technology in Improving Adherence Therapy
Official title: HYPERTENSIVE PATIENT ADHERENCE TO TREATMENT: THE USE OF THERAPEUTIC COMMUNICATION ASSOCIATED WITH TECHNOLOGY EDUCATIONAL IN HEALTH PROMOTION"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Nonadherence
Hypertension, Resistant to Conventional Therapy
Keywords: Hypertension
Tecnology
Nursing
Education
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Luiz Aparecido Bortolotto
name: Chao Lung Wen
name: Margarida Vieira
name: Miriam Harume Tsunemi
name: Isabela Ribeiro Braga Fistarol
name: Jefferson Carlos de Oliveira
name: Dante Marcelo Artiga Giorgi
name: Heno Ferreira Lopes
name: Fernanda Marciano Consolim-Colombo
name: Ivonete Sanches Giacometti Kowalski
First posted: 2017-10-27
Enrollment: 57
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

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)

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.

Eligibility criteria: 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. -

Primary outcomes:
measure: measure blood arterial pressure
timeFrame: 4 months
measure: Ambulatory Blood Pressure monitoring
timeFrame: 4 months
measure: Pill count
timeFrame: up to 4 months
Secondary outcomes:
measure: The brief version of the World Health Organization quality of life (WHOQOL-BREF)
timeFrame: 4 months
measure: The Duke University Religion Index (DUREL) for a brief measure of religiosity that can be included between religion and health outcomes.
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
References: