Evaluation of a Transmedial Psychoeducational Program to Improve Pharmacological Adherence

NCT03924115 | Completed

• 2 other identifiers: AFAM2017FONDEF ID16AM0007
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

Brief Summary

Population in Chile has experienced an accelerated process of demographic aging, which leads to changes in the composition of morbidity and mortality, with chronic noncommunicable diseases currently predominating. One of the main problems in the treatment of people with chronic and asymptomatic pathologies such as essential arterial hypertension is the lack of pharmacological adherence, where approximately 50% farewell to the treatment, while the remaining 50% partially adheres, does not adhere or interrupt within the first year. The solution is a Psychoeducational Transmedial Program to improve pharmacological adherence (PTA), as a support to the current treatment found in centers of primary health (CESFAM). The PTA program offers health promotion and education proposals through video capsules transmitted in CESFAM. The full PTA program also includes an AFAM-Health phone application in which older adults can know and control the administration of their medications, schedule medication registration alerts, have access to healthy life information and pathology information, Incorporated a community through a chat that generates support and accompaniment among the participants themselves. The aim of the study is to evaluate if Transmedial Psychoeducational Program improves the pharmacological adherence of the antihypertensive treatment in elderly people receiving medical attention at CESFAM Hualpen, in Chili. A clinical trial was conducted with 3 parallel groups of older adults diagnosed with Essential Arterial Hypertension. There were 2 treatment groups (A and B) and a control group (C). Group A was exposed to the full PTE transmedial psychoeducational program that includes a cell phone with the application developed to improve adherence and data plan. Group B received the program without the mobile application. All participants were given a Morisky-Green test to measure pharmacological adherence and an instrument developed by the clinical team to measure the biopsychosocial characteristics of elderly under study. t is expected to find that the pharmacological adherence of those receiving the full PST is significantly superior to the control group, and those who receive the partial PST are significantly superior to the control group.

Conditions

Essential Hypertension

Keywords

Adherence, Hypertension, Mobil App, video

Outcome Measures

Primary Outcomes (1)

• Adherence

  Pharmacological adherence measured with a standardized questionnaire Morisky-Green Test

  one year

Secondary Outcomes (1)

• Disease knowledge or beliefs Disease knowledge or belief

  one year

Study Arms (3)

Group Total

EXPERIMENTAL

This group of patients was chosen at random. They are patients who receive the full PST as intervention, that is, they receive a Smartphone with the AFAM-Health application with all the contents of the PST and data plan for 1 year.

Device: Transmedial Psychoeducational Program to improve adherence full or partial (PS)

Group Partial

EXPERIMENTAL

This group of patients was chosen at random under the criteria of parity with group A. They are patients who receive partial PST as intervention, that is, they only receive video capsules reproduced in the CESFAM waiting room as educational content.

Device: Transmedial Psychoeducational Program to improve adherence full or partial (PS)

Group Control

NO INTERVENTION

This group of patients is the control group, that is, they do not receive any type of intervention additional to the one they already receive from their CESFAM.

Interventions

Transmedial Psychoeducational Program to improve adherence full or partial (PS) DEVICE

Intervention consists of a transmedial Psychoeducational Program, which includes cognitive, behavioral and affective aspects to generate knowledge and skills that improve self-efficacy in the elderly, it is a program based on communication in health. The proposed transmedial narrative will allow older adults to assemble information from messages arranged through various media, including audiovisual capsules that will be transmitted on screens located in the Health Center and the development of a mobile application incorporated in the cellular that will be delivered with a data plan for one year. This intervention is designed to strengthen the personal resources of the elderly (such as self-efficacy, empowerment, knowledge) that promote self-care in health.

Group Partial; Group Total

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People under treatment for hypertension
• Both sexes
• Older than 60 years
• Autovalent
• read and write

You may not qualify if:

• Under treatment for severe psychiatric pathology
• Mental retardation.

Sponsors & Collaborators

• Universidad de Concepcion: lead
• Comisión Nacional de Investigación Científica y Tecnológica: collaborator

Study Sites (1)

Universidad de Concepción

Concepción, 4070386, Chile

Location

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hans Muller, MD

  Universidad de Concepcion

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Being treatment supportive care, patients and researchers know who are the participants of the different levels of intervention. The health professionals who attend both CESFAM do not have access to the information of the patients under study, as well as the evaluation of results, to avoid biases both in the care of patients and in the analysis of results. The results evaluator will receive the instrument data and validated questionnaires in previously typed code forms.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical trial with a 3 parallel groups of hypertensive elderly people in 2 primary health center (CESFAM). Group A was chosen at random in CESFAM Hualpencillo, Groups B and C were selected by pairing with group A, in CESFAM Hualpencillo and Talcahuano Sur, respectively. The match was made based on 5 criteria: sex, age (± 5 years), educational level, co-morbidities (diabetes mellitus 2, chronic kidney disease and heart failure) and adherence (adherent or non-adherent). Persons who agreed to participate signed an informed consent before, to be recruited. In Group A, patients were given a smartphone with a data plan for 1 year. In each evaluations, group activities were carried out in CESFAM and home visits to those who did not attend. In each evaluation the instrument developed by the same research team was applied. For updating drugs prescription, in mobile application and collection of clinical data such as tests and controls, weekly visits were made to CESFAM.

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 23, 2019
• Study Start: October 10, 2017
• Primary Completion: December 31, 2018
• Study Completion: April 1, 2019
• Last Updated: May 6, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)