Clinical trial NCT03924115: Evaluation of a Transmedial Psychoeducational Program to Improve Pharmacological Adherence
Official title: Evaluation of a Transmedial Psychoeducational Program to Improve Pharmacological Adherence in Hypertensive Elderly Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Hypertension
Keywords: Adherence, Hypertension, Mobil App, video
Lead sponsor: Universidad de Concepcion
Sponsor class: OTHER
Collaborators: name: Comisión Nacional de Investigación Científica y Tecnológica
First posted: 2019-04-23
Enrollment: 215
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Data fingering: The data of the instrument recorded on paper are typed by an external professional.

Data analysis: Databases are delivered to a statistical researcher for data analysis Type of design: The comparisons to be made are of two types, between groups (Control and two treatments) and within each group (baseline measurements and measurements with intervention). In both cases, they have paired samples, since it is proposed to pair the groups.

Comparisons between groups: To calculate the sample size of each group, the specification of the correlation of scores between groups is required; but the more correlated the groups are, the smaller the sample sizes, so the worst case was chosen, that is, calculating sample sizes relative to comparison of independent samples (unpaired), a method known as "Analysis of Variance ", so that this sample is more than sufficient for any correlation achieved between groups. Under the specifications outlined above, n = 99 cases are required for each group Comparisons within the same group: To calculate the sample size of each group, it is required to specify the standard deviation of the differences, which is less than the standard deviation by itself; therefore, the same value of the standard deviation was considered, which leads to sampling sizes higher than those required, so that the calculated sample is more than sufficient for the case of interest. Under the specifications outlined above, n = 37 cases are required for each group.

In view of the above, samples of size n = 100 for each group are more than sufficient for the proposed objectives.

The statistical analysis will be developed in several stages Stage 1: Verification of the homogeneity of the groups in the pre-intervention stage, in relation to all available variables. For this purpose, it is assessed that there is, in the three groups: Equality of means of the quantitative variable Age. The statistical test is ANOVA (Alternative nonparametric Kruskal-Wallis, in the absence of normality). Equality of the proportions of the categorical variables sex, socioeconomic level, educational level, Marital status, Live children; These proportions must be similar by pairing. The statistical test is the homogeneity of Chi-Square proportions (Fisher's exact test, R-Project software).Homogeneity of variables not used in pairing. Tests analogous to those previously known (number of living children, digital literacy, etc.).

Stage 2: Once the groups are constituted according to their homogeneity with respect to the independent variables, the homogeneity of the groups in the pre-intervention stage is verified, in relation to the variables Pharmacological Adherence of the Antihypertensive Treatment (dependent) and Self-efficacy (independent ) in pre-test version. For this purpose, it will be evaluated that there is, in the three groups:

Equality of means of the quantitative variable Self-efficacy. Statistical test: ANOVA; alternative: Kruskal-Wallis.

Equality of proportions for variable Adherence. Statistical test: Square Chi; Alternative: Fisher's Exact Test.Homogeneity of the relationships between adherence and self-efficacy. Statistical test: ANOVA, two-ways (Adherence and Group). It is expected that none of the groups reflect a significant baseline relationship between these variables.

In case of lack of homogeneity, the pairing will be reviewed, to achieve homogeneous groups at the base level.

Stage 3: After 3 months of intervention (period of the first post-test measurement), the instrument is again applied to measure adherence in the three groups. At this time, the effect of desertions (dropouts) on the results of the study should be considered, verifying the homogeneity of the groups by repeating the statistical tests of stages 1 and 2 for the groups that remain in the study. If the homogeneity is altered, the complete trio linked to each subject that defects will be eliminated from the measurements. Otherwise, it continues with the groups as they are in this stage.

Stage 4: Once the groups of people who remain in the study have been defined, the effect of the intervention (in its 2 levels, A and B) must be evaluated, with respect to the results of group C (control), through measurements of the post-test third month.

For this purpose, it will be evaluated in the three groups there is:

Homogeneity of proportions for Adherence in the three groups. Statistical test: McNemar, Significant differences are expected in treatment A and eventually B, and homogeneity of the control group; Alternative: Logistic regression (covariables: Group, Basal Adherence, Baseline Self-efficacy, Response Adherence to month 3, the Group is expected to be significant).

In case of significant differences (alpha = 0.05), the effect size is evaluated, expecting greater effects in Group A, followed by B and C.

Stages 5 and 7: They coincide with stage 3, but in months 6 and 12, respectively.

Stage 6: After 6 months of intervention, defined the participants who continue in the study (by stage 5), the procedure of stage 4 is repeated, to define if there are changes in the Adherence, with respect to basal adherence and with respect to the adherence to month 3 (which is added as a covariate).

In addition, counting on Self-efficacy measurement, it is interesting to evaluate their changes:

It is verified if there is equality of means for Self-efficacy of month 6. Statistical test: ANOVA; alternative: Kruskal-Wallis. Factors: Group and Adherence to month 3, covariate: Baseline self-efficacy, with different slopes according to the group. It would be expected that there is a significant group effect and a difference in slopes.

If significant differences are found (alpha = 0.05), the groups that present these differences are evaluated. Statistical test: multiple LSD-Fisher comparisons; alternatives: non-parametric type Bonferroni (lacking normality). They also compare slopes. Statistical test: contrasts.

Step 2 is repeated for homogeneity of adherence-self-efficacy relationships. Stage 8: After 12 months of intervention, that is, at the end of the study period, stage 6 is repeated.

Stage 9: With all the data of evolution of pharmacological adherence to antihypertensive treatment by the members of the three samples and their respective self-efficacy, an analysis of repeated measures is performed. This analysis allows discriminating between individual, temporary and treatment effects; evaluating the longitudinal aspect of the intervention. It is completed by measuring again the correlation between adherence and self-efficacy.

Eligibility criteria: 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.

Primary outcomes:
measure: Adherence
timeFrame: one year
Secondary outcomes:
measure: Disease knowledge or beliefs Disease knowledge or belief
timeFrame: one year
Other outcomes:
Locations:
city: Concepción
country: Chile
facility: Universidad de Concepción
Study officials:
affiliation: Universidad de Concepcion
name: Hans Muller, MD
role: STUDY_CHAIR
References: