Evaluation of a Transmedial Psychoeducational Program to Improve Pharmacological Adherence in Hypertensive Elderly Persons
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Concepcion
- Enrollment
- 215
- Locations
- 2
- Primary Endpoint
- Adherence
Study Overview
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.
Detailed Description
The validation was carried out in two stages, before and after pilot. First, expert evaluation , in terms of five validation criteria: clarity, impartiality, relevance, and importance of each relevant question or reagents. Secondly, the results of application to pilot sample were analyzed in two ways, question by question, according to contribution of the same, and by dimensions and sub-dimensions in terms of common factors that these have.
Data collected in the instrument by interviewers is contrasted with information in the clinical file of patients. The none Data dictionary that contains detailed descriptions of each variable has been used by the registry.
Recruitment of patients: The selected patients are contacted via telephone and are summoned to a meeting at CESFAM to publicize the project, answer questions and if they wish to participate, sign informed consent. Volunteers who cannot attend these meetings are visited in their homes and the same procedure described above is performed.
Data collection: The application of the instrument is carried out by student surveyor, with home visits and paper records, trained by the research team and under the permanent supervision of 2 researchers.
Clinical data that include vital signs, exams and controls are compiled from the corresponding CESFAM, each study group having a researcher in charge. Data for medication administration are automatically registered in AFAM-Health Web App.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •People under treatment for hypertension
- •Both sexes
- •Older than 60 years
- •Autovalent
- •read and write
Exclusion Criteria
- •Under treatment for severe psychiatric pathology
- •Mental retardation.
Arms & Interventions
Group Total
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.
Intervention: Transmedial Psychoeducational Program to improve adherence full or partial (PS) (Device)
Group Partial
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.
Intervention: Transmedial Psychoeducational Program to improve adherence full or partial (PS) (Device)
Group Control
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.
Outcomes
Primary Outcomes
Adherence
Time Frame: one year
Pharmacological adherence measured with a standardized questionnaire Morisky-Green Test
Secondary Outcomes
- Disease knowledge or beliefs Disease knowledge or belief(one year)