The Effect ''of Follow-up With the Mobile Application'' on Treatment Compliance in Patients With Hypertension

April 18, 2022 updated by: Alev Yıldırım Keskin, Selcuk University

The Effect on Treatment Compliance and Self-Care Management in Patients With Hypertension

Hypertension is an important disease that generally affects the adult population, is increasing rapidly in our country and in the world, and threatens public health due to its complications. In our country, the rate of blood pressure control in patients receiving antihypertensive treatment is 53.9%. One of the factors that play a role in not exceeding this rate is the patient's non-compliance with treatment.

Hypertension management has two main building blocks. These are: lifestyle improvement and drug therapy. According to the data of the World Health Organization, the rate of compliance with treatment in chronic diseases in developing countries is around 50%. Morbidity and mortality are directly related to the use of drugs in patients with hypertension, and the control of hypertension is possible with the patient's compliance with the treatment. Among the reasons for non-compliance with treatment; The side effects of drugs, the patient's insecurity about the effectiveness and benefit of the treatment, lack of motivation, the absence of disturbing physical symptoms in some patients, lack of knowledge about drug therapy and diet regimens, miscommunication between the patient and the physician, the complexity of the treatment, and insufficient participation in the follow-up of the patient can be counted. It is important to support and follow-up the hypertensive individual in order to develop their self-care skills and to adapt and maintain their lifestyle changes and drug treatment to keep their blood pressure under control.

The use of mobile health services is becoming more and more popular in the self-management of chronic diseases such as hypertension. Due to the rapid adoption of smartphone technologies, mobile phones are now attracting the attention of individuals with chronic diseases and increasing their usability, thanks to their entertaining use as well as monitoring patient data, providing personalized self-management, benefiting from social effects.

This study was planned to determine the "Effect of Mobile Application Use on Treatment Adherence and Self-Care Management in Patients with Hypertension". The study was designed to improve individuals' knowledge about the disease, regular drug use, diet compliance, physical activity level, quitting smoking and alcohol if using, and weight control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This research was planned as a randomized controlled study in the pre-test post-test evaluation order before and after the mobile application in order to determine the "Effect of Mobile Application Use on Treatment Adherence and Self-Care Management in Patients with Hypertension".

The research was carried out between 22.11.2021-03.01.2022. It is planned to be conducted with patients who applied to the Cardiology Polyclinic of City Hospital and who were diagnosed with essential hypertension at least 1 year ago and met the research criteria.

The sample of the study, on the other hand, will consist of patients aged 18 and over, who were diagnosed at least 1 year ago, who were diagnosed with hypertension, who applied to the hypertension outpatient clinic, who were treated with antihypertensive drugs, who met the inclusion criteria of the study, and who volunteered to participate in the study. G-power program was used for power calculation of the study. Accordingly, it was calculated that at least 30 participants in each group were required for a difference of at least 5% between the control and intervention groups to be significant at the 95% confidence interval for 80% power. When the 10% loss that may occur during the follow-up of the patients is added to this number, it was planned to include at least 33 participants for both groups.

Sample selection in this study; Randomization will be performed by a person who was not involved in the study in the computer environment. Those with odd number of patient registration numbers will be Group 1: Intervention (Training Group), those with even number of patient registration numbers will be Group 2: Control Group.

Group 1: To be followed by the researchers for 4 weeks with a mobile application; This is the training group in which individual motivational messages will be sent to the mobile phones every week for compliance with the diet, exercise and drug therapy of the patients, and the weekly average of blood pressure follow-ups will be monitored over the system.

Group 2: It is the control group whose routine outpatient follow-up will continue and no training is given.

Data Collection Tools to be Used in the Study: Data collection form will be collected with "Hill-Bone Hypertension Treatment Adherence Scale", "Hypertension Self-Care Profile Scale".

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey, 42550
        • Alev YILDIRIM KESKİN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Volunteering to participate in the study,
  • Being followed in the outpatient clinic with the diagnosis of hypertension for the last 1 year,
  • Using antihypertensive medication
  • Being a smart mobile phone user,
  • 18 years of age and over
  • Not having any communication problems such as seeing or hearing,
  • Ability to read and write

Exclusion Criteria:

  • Those who lost their lives during the research,
  • Those who want to leave the research voluntarily at any stage of the research,
  • Patients who fill in the forms incompletely and have missing data will be excluded from the study.
  • Being illiterate
  • Having communication problems such as seeing and hearing,
  • Not being willing to participate in the study,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The Effect ''of Follow-up with the Mobile Application'' in Patients with Hypertension
Intervention Group:mobile application for 4 weeks; This is the training group in which individual motivational messages will be sent to the mobile phones every week for compliance with the diet, exercise and drug therapy of the patients, and the weekly average of blood pressure follow-ups is monitored over the system.
Behavioral: The Effect of the Mobile Application
This study was planned to determine the "Effect of Mobile Application Use on Treatment Adherence and Self-Care Management in Patients with Hypertension". The study was designed to improve individuals' knowledge about the disease, regular drug use, diet compliance, physical activity level, quitting smoking and alcohol if using, and weight control.
No Intervention: The Effect ''of Follow-up with the Mobile Application'' in Hypertension control group
It is the control group whose routine outpatient follow-up will continue and no training is given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure value
Time Frame: 6 weeks
The average blood pressure values of the patients will be taken at the end of 24 hours by attaching a blood pressure holter.
6 weeks
Hypertension Self-Care Profile Scale
Time Frame: 6 weeks
Motivation of patients; It is a 20-item Likert-type scale evaluating not important=1, somewhat important=2, important=3, very important=4. The scale results in a score between 20 and 80. A higher score indicates better self-care of a patient with hypertension.
6 weeks
Hill-Bone Hypertension Treatment Adherence Scale
Time Frame: 6 weeks
The scale consists of 14 questions of 4-point Likert type. The answers include (0) "Never", (1) "Sometimes", (2) "Often" and (3) "Always". The scale total score ranges from 0 to 42. The higher the score, the lower the fit.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Selcuk University

Investigators

  • Principal Investigator: Alev YILDIRIM KESKİN, Asst. Prof, Selcuk University/ School of Health, KONYA, TURKEY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2021

Primary Completion (Actual)

January 15, 2022

Study Completion (Actual)

January 30, 2022

Study Registration Dates

First Submitted

March 14, 2022

First Submitted That Met QC Criteria

April 18, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 18, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/19
  • 2021/484 (Registry Identifier: Mobile Application in Patients with Hypertension)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on The Effect of the Mobile Application

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe