NCT07050303

Brief Summary

In this study, a mobile application designed based on the Social Cognitive Theory was evaluated in middle-aged individuals with hypertension: H1(a): A mobile application based on the Social Cognitive Theory affects medication adherence self-efficacy levels in patients with hypertension. H0(a): A mobile application based on the Social Cognitive Theory does not affect medication adherence self-efficacy levels in patients with hypertension. H1(b): A mobile application based on the Social Cognitive Theory affects hypertension self-efficacy levels in patients with hypertension. H0(b): A mobile application based on the Social Cognitive Theory does not affect hypertension self-efficacy levels in patients with hypertension. H1(c): A mobile application based on the Social Cognitive Theory affects systolic and diastolic blood pressure levels in patients with hypertension. H0(c): A mobile application based on the Social Cognitive Theory does not affect systolic and diastolic blood pressure levels in patients with hypertension. Participants were asked to download and use the hypertension monitoring application designed by the researcher on their phones for a period of three months. A pre-test was administered through face-to-face interviews before installing the application. After using the application for three months, a post-test was conducted using the same scales through face-to-face interviews. For the control group, the same pre-test was administered through face-to-face interviews without using the application. After three months, a post-test was again conducted via face-to-face interviews. The researchers compared the data of the participants with those of the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Dec 2024

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

December 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

January 29, 2025

Last Update Submit

June 24, 2025

Conditions

Keywords

HypertensionMobile ApplicationSocial Cognitive Learning TheoryPublic Health NursingHypertension Self-Efficacy ScaleMedication Adherence Self-Efficacy Scale

Outcome Measures

Primary Outcomes (2)

  • Medication Adherence Self-Efficacy Level in Hypertension Patients

    A mobile app can influence medication adherence self-efficacy levels in hypertension patients.

    From participation until the end-point is 3 months.

  • Hypertension Self-Efficacy Level in Hypertension Patients

    A mobile app influences hypertension self-efficacy levels in hypertension patients.

    From participation until the end-point is 3 months.

Secondary Outcomes (1)

  • systolic and diastolic blood pressure

    From participation until the end-point is 3 months.

Study Arms (2)

Participitants

EXPERIMENTAL

Mobile application users

Other: Mobile Application Developed Based on Social Cognitive Theory

Control

NO INTERVENTION

non-users of application

Interventions

Measuring the Benefits of a 3-Month Mobile Application Use in Hypertension Patients

Participitants

Eligibility Criteria

Age41 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with hypertension (for at least 6 months).
  • Currently using antihypertensive medication.
  • Voluntarily agrees to participate in the research.
  • Aged between 40-64 years (Turkish Society of Hypertension and Renal Diseases, 2012; TURKSTAT, 2022).
  • Literate.
  • No mental or communication-impairing issues.
  • Not pregnant or a breastfeeding mother.
  • Able to use a smartphone with an Android operating system.
  • No additional comorbid diseases (e.g., cancer, diabetes mellitus).
  • Has a semi-automatic upper-arm blood pressure monitor at home.

You may not qualify if:

  • Experiencing issues with internet access or mobile application usage.
  • Voluntarily withdraws from the study during the research process.
  • Uses an different operating system than Android operating system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes University

Aydin, Efeler, 09010, Turkey (Türkiye)

Location

Related Publications (25)

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    PMID: 32501962BACKGROUND
  • WHO guideline Recommendations on Digital Interventions for Health System Strengthening. Geneva: World Health Organization; 2019. Available from http://www.ncbi.nlm.nih.gov/books/NBK541902/

    PMID: 31162915BACKGROUND
  • Zhang Q, Huang F, Zhang L, Li S, Zhang J. The effect of high blood pressure-health literacy, self-management behavior, self-efficacy and social support on the health-related quality of life of Kazakh hypertension patients in a low-income rural area of China: a structural equation model. BMC Public Health. 2021 Jun 10;21(1):1114. doi: 10.1186/s12889-021-11129-5.

    PMID: 34112122BACKGROUND
  • Yang S, He C, Zhang X, Sun K, Wu S, Sun X, Li Y. Determinants of antihypertensive adherence among patients in Beijing: Application of the health belief model. Patient Educ Couns. 2016 Nov;99(11):1894-1900. doi: 10.1016/j.pec.2016.06.014. Epub 2016 Jun 18.

    PMID: 27378081BACKGROUND
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    PMID: 31521340BACKGROUND
  • Arici M, Birdane A, Guler K, Yildiz BO, Altun B, Erturk S, Aydogdu S, Ozbakkaloglu M, Ersoz HO, Suleymanlar G, Tukek T, Tokgozoglu L, Erdem Y; Turk Kardiyoloji Derneg i (TKD); Turk Ic Hastaliklari Uzmanlik Dernegi (TIHUD); Turkiye Endokrinoloji ve Metabolizma Dernegi (TEMD); Turk Nefroloji Dernegi (TND); Turk Hipertansiyon ve Bobrek Hastaliklari Dernegi. [Turkish Hypertension Consensus Report]. Turk Kardiyol Dern Ars. 2015 Jun;43(4):402-9. doi: 10.5543/tkda.2015.16243. Turkish.

    PMID: 26142798BACKGROUND
  • Tezcan C, (2016). Sağlığa Yenilikçi Bir Bakış Açısı: Mobil Sağlık. Yayın No: TÜSİAD-T/2016-03/575

    BACKGROUND
  • Sümen A. (2019). Sosyal Bilişsel Teoriye Temellendirilmiş ' Çocuğumu Güneşten Koruyorum' Programının Ebeveyn Davranışlarına Etkisi, Doktora Tezi, Akdeniz Üniversitesi Sağlık Bilimleri Enstitüsü, Antalya.

    BACKGROUND
  • Shen Y, Chang C, Zhang J, Jiang Y, Ni B, Wang Y. Prevalence and risk factors associated with hypertension and prehypertension in a working population at high altitude in China: a cross-sectional study. Environ Health Prev Med. 2017 Apr 4;22(1):19. doi: 10.1186/s12199-017-0634-7.

    PMID: 29165123BACKGROUND
  • Saleh S, Farah A, Dimassi H, El Arnaout N, Constantin J, Osman M, El Morr C, Alameddine M. Using Mobile Health to Enhance Outcomes of Noncommunicable Diseases Care in Rural Settings and Refugee Camps: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jul 13;6(7):e137. doi: 10.2196/mhealth.8146.

    PMID: 30006326BACKGROUND
  • Özpulat F. (2015). Motivasyonel Görüşmenin Hipertansif Bireylerin Özyeterlilik Algısına ve İlaç Tedavisi Uyumuna Etkisi, Hacettepe Üniversitesi Sağlık Bilimleri Enstitüsü, Doktora Tezi, Ankara.

    BACKGROUND
  • Matar D, Frangieh AH, Abouassi S, Bteich F, Saleh A, Salame E, Kassab R, Azar RR. Prevalence, awareness, treatment, and control of hypertension in Lebanon. J Clin Hypertens (Greenwich). 2015 May;17(5):381-8. doi: 10.1111/jch.12485. Epub 2015 Jan 24.

    PMID: 25619545BACKGROUND
  • Lu J, Lu Y, Wang X, Li X, Linderman GC, Wu C, Cheng X, Mu L, Zhang H, Liu J, Su M, Zhao H, Spatz ES, Spertus JA, Masoudi FA, Krumholz HM, Jiang L. Prevalence, awareness, treatment, and control of hypertension in China: data from 1.7 million adults in a population-based screening study (China PEACE Million Persons Project). Lancet. 2017 Dec 9;390(10112):2549-2558. doi: 10.1016/S0140-6736(17)32478-9. Epub 2017 Nov 5.

    PMID: 29102084BACKGROUND
  • Kurt (2020). Hipertansiyon Tanısı Alan Hastalara Verilen Öz Yönetim Desteğinin Bilgi Düzeyi, Tedaviye Uyum Ve Öz Bakım Yönetimine Etkisi. Doktora Tezi. Trakya Üniversitesi Sağlık Bilimleri Enstitüsü, Edirne.

    BACKGROUND
  • Kumar N, Khunger M, Gupta A, Garg N. A content analysis of smartphone-based applications for hypertension management. J Am Soc Hypertens. 2015 Feb;9(2):130-6. doi: 10.1016/j.jash.2014.12.001. Epub 2014 Dec 11.

    PMID: 25660364BACKGROUND
  • Kaynak, G. K. Kronik hastalıklarda öz yeterlilik algısı: Türkiye'de gerçekleştirilen çalışmalar üzerine bir derleme. Oltu Beşeri ve Sosyal Bilimler Fakültesi Dergisi, 3(2), 79-86.

    BACKGROUND
  • Karadağ, E., Karatay, G., Akkuş, Y.(2012) Bir Aile Sağlığı Merkezine Başvuran Hipertansiyon Hastalarının İlaç Tedavisine Uyum Öz Etkililik Düzeyleri. Ege Üniversitesi Hemşirelik Fakültesi Dergisi, 28(3), 85-96.

    BACKGROUND
  • Hyder AA, Wosu AC, Gibson DG, Labrique AB, Ali J, Pariyo GW. Noncommunicable Disease Risk Factors and Mobile Phones: A Proposed Research Agenda. J Med Internet Res. 2017 May 5;19(5):e133. doi: 10.2196/jmir.7246.

    PMID: 28476722BACKGROUND
  • Hacıhasanoglu, R., Gözüm, S., ve Çapık, C. (2012). Hipertansif Hastalarda İlaca Uyum Öz-etkililik Ölçegi kısa formunun Türkçe'sinin geçerliligi. Anadulu Kardiyoloji Dergisi, 12(3), 241-248.

    BACKGROUND
  • Gönel, P. (2019). Hastaların Hipertansiyon Bilgilerinin Tedaviye Uyum ve Öz-Etkililik Düzeylerine Etkisinin Belirlenmesi (Master's thesis, Eastern Mediterranean University (EMU)-Doğu Akdeniz Üniversitesi (DAÜ)

    BACKGROUND
  • Dikmen Y. Denar Y. Başan H. Filiz N.Y, Hemşirelik Öğrencilerinin Öz Etkinlik-Yeterlilik Düzeylerinin İncelenmesi. Çağdaş Tıp Dergisi 2016,6(3),206-2013

    BACKGROUND
  • Delibaş, L., Erci, B.(2021). Sosyal Bilişsel Kuram Temelli Eğitimle Tip 1 Diyabetli Çocukların Hastalık Yönetiminin Desteklenmesi. Turkish Journal of Family Medicine and Primary Care, 15(2), 404-413.

    BACKGROUND
  • Buis L, Hirzel L, Dawood RM, Dawood KL, Nichols LP, Artinian NT, Schwiebert L, Yarandi HN, Roberson DN, Plegue MA, Mango LC, Levy PD. Text Messaging to Improve Hypertension Medication Adherence in African Americans From Primary Care and Emergency Department Settings: Results From Two Randomized Feasibility Studies. JMIR Mhealth Uhealth. 2017 Feb 1;5(2):e9. doi: 10.2196/mhealth.6630.

    PMID: 28148474BACKGROUND
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    BACKGROUND
  • Bahar B, Sosyal Öğrenme Kuramı Ve Sosyal Değişim Kuramı Perspektifinden Etik Liderlik. Balkan Sosyal Bilimler Dergisi 2019,8(16),237-242

    BACKGROUND

Related Links

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Adile TÜMER, Assosciate Professor

    Muğla Sıtkı Koçman University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 29, 2025

First Posted

July 3, 2025

Study Start

December 1, 2024

Primary Completion

March 1, 2025

Study Completion

May 1, 2025

Last Updated

July 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations