NCT05334446

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 14, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

March 14, 2022

Last Update Submit

April 18, 2022

Conditions

Keywords

HypertensionMobile ApplicationTreatment ComplianceSelf Care Management

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

The Effect ''of Follow-up with the Mobile Application'' in Patients with Hypertension

EXPERIMENTAL

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

The Effect ''of Follow-up with the Mobile Application'' in Hypertension control group

NO INTERVENTION

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

Interventions

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.

The Effect ''of Follow-up with the Mobile Application'' in Patients with Hypertension

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,
  • years of age and over
  • Not having any communication problems such as seeing or hearing,
  • Ability to read and write

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alev YILDIRIM KESKİN

Konya, 42550, Turkey (Türkiye)

Location

Related Publications (7)

  • Marquez Contreras E, Marquez Rivero S, Rodriguez Garcia E, Lopez-Garcia-Ramos L, Carlos Pastoriza Vilas J, Baldonedo Suarez A, Gracia Diez C, Gil Guillen 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.

    PMID: 30431384BACKGROUND
  • Kang H, Park HA. Development of Hypertension Management Mobile Application based on Clinical Practice Guidelines. Stud Health Technol Inform. 2015;210:602-6.

    PMID: 25991219BACKGROUND
  • 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.

    PMID: 25903164BACKGROUND
  • 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.

    PMID: 26456490BACKGROUND
  • 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.

    PMID: 21348564BACKGROUND
  • Bengtsson U, Kjellgren K, Hallberg I, Lundin M, Makitalo A. 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.

    PMID: 29343156BACKGROUND
  • Yildirim Keskin A, Ozpancar Solpan N, Degirmenci H. The Effect of Mobile Application Follow-Up on Treatment Compliance and Self-Care Management in Patients With Hypertension: Randomized Controlled Trial. Public Health Nurs. 2025 Jan-Feb;42(1):275-285. doi: 10.1111/phn.13476. Epub 2024 Nov 4.

MeSH Terms

Conditions

HypertensionPatient Compliance

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Alev YILDIRIM KESKİN, Asst. Prof

    Selcuk University/ School of Health, KONYA, TURKEY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The Effect ''of Follow-up With the Mobile Application'' on Treatment Compliance with the intervention group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 14, 2022

First Posted

April 19, 2022

Study Start

November 15, 2021

Primary Completion

January 15, 2022

Study Completion

January 30, 2022

Last Updated

April 19, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations