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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05334446
• Other study ID #: 2021/19
• Secondary ID: 2021/484
• Status: Completed
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: January 30, 2022

Study information

• Verified date: April 2022
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 30, 2022
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
Turkey	Alev YILDIRIM KESKIN	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Bengtsson U, Kjellgren K, Hallberg I, Lindwall M, Taft C. Improved Blood Pressure Control Using an Interactive Mobile Phone Support System. J Clin Hypertens (Greenwich). 2016 Feb;18(2):101-8. doi: 10.1111/jch.12682. Epub 2015 Oct 12. — View Citation

Bengtsson U, Kjellgren K, Hallberg I, Lundin M, Mäkitalo Å. Patient contributions during primary care consultations for hypertension after self-reporting via a mobile phone self-management support system. Scand J Prim Health Care. 2018 Mar;36(1):70-79. doi: 10.1080/02813432.2018.1426144. Epub 2018 Jan 18. — View Citation

Cutrona SL, Choudhry NK, Fischer MA, Servi A, Liberman JN, Brennan TA, Shrank WH. Modes of delivery for interventions to improve cardiovascular medication adherence. Am J Manag Care. 2010;16(12):929-42. Review. — View Citation

Hallberg I, Ranerup A, Kjellgren K. Supporting the self-management of hypertension: Patients' experiences of using a mobile phone-based system. J Hum Hypertens. 2016 Feb;30(2):141-6. doi: 10.1038/jhh.2015.37. Epub 2015 Apr 23. — View Citation

Kang H, Park HA. Development of Hypertension Management Mobile Application based on Clinical Practice Guidelines. Stud Health Technol Inform. 2015;210:602-6. — View Citation

Márquez Contreras E, Márquez Rivero S, Rodríguez García E, López-García-Ramos L, Carlos Pastoriza Vilas J, Baldonedo Suárez A, Gracia Diez C, Gil Guillén V, Martell Claros N; Compliance Group of Spanish Society of Hypertension (SEH-LELHA). Specific hypertension smartphone application to improve medication adherence in hypertension: a cluster-randomized trial. Curr Med Res Opin. 2019 Jan;35(1):167-173. doi: 10.1080/03007995.2018.1549026. Epub 2018 Dec 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure value	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
Primary	Hypertension Self-Care Profile Scale	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
Primary	Hill-Bone Hypertension Treatment Adherence Scale	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