Investigation of the Effect of Mobile Software Use in Blood Pressure Management of Hypertensive Individuals on Quality of Life and Disease Self-Efficacy

NCT06321159 | Recruiting DMC

• 1 other identifier: Nursing Dep.
• Study Type: interventional
• Target: 614
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertension is a prevalent health concern, affecting one in three adults globally, with the potential to lead to fatal complications. However, an alarming proportion of those diagnosed-four out of five individuals-struggle to effectively manage this condition. As such, the effective management of hypertension becomes paramount. A study conducted post-earthquake by a principal investigator and a scholarship recipient revealed that 47.9% of participants received a hypertension diagnosis, and a significant 67.8% ceased active management of the condition. Existing literature suggests a notable decline in the quality of life among individuals unable to manage hypertension effectively. While current research emphasizes the components of nutrition, exercise, and medication adherence in hypertension management, the integration of these components into mobile applications is notably lacking. This project seeks to enhance disease management for users by integrating crucial elements, including blood pressure measurement, into a user-friendly mobile application, thereby providing a distinctive contribution. The proposed application encompasses the recording of vital signs, integration of customized diet and exercise programs tailored for hypertension, and provision of consultancy services for identifying deviations in health status and implementing appropriate interventions. The integration of these components is anticipated to contribute to preventing or minimizing potential complications for the patient. Comprehensive studies incorporating such an approach are rarely encountered in the existing literature, enhancing the originality of this research. The projects overarching goal is to enable individuals to manage hypertension even in extraordinary circumstances, such as earthquakes. Consequently, the study will assess how the mobile application influences individuals; quality of life and disease self-efficacy. Conducted between April 2024 and January 2026, the project adopts a pre-test post-test control group experimental design in the four most earthquake-affected provinces. It involves 614 individuals diagnosed with hypertension, residing in temporary living space in Malatya, Hatay, Kahramanmaraş, and Adıyaman, with 78, 77, and 74 participants in Malatya, Hatay, and Adıyaman, respectively. Data collection tools include the Personal Identification Information Form, Hypertension Self-Efficacy Scale, SF-36 Quality of Life Scale, and International Physical Activity Scale-Short Form, administered through face-to-face interviews. The mobile application development will be a collaborative effort with two faculty members from the Department of Computer Engineering and expert academicians. For the diet program within the application, eight questions will be used to uncover individuals\' dietary preferences. Calculations based on Body Mass Index, basal metabolic rate, and daily energy requirements will inform the diet program, which will encompass five food groups and their caloric values. Notifications about diet adherence will be sent for each meal. In the exercise program, individuals will measure and record blood pressure and medication intake. Those with a blood pressure of 140/90 mmHg or higher will be included based on expert physician recommendations, with notifications for those exceeding 160/100 mmHg to consult a physician. A personalized exercise program will be created based on the OMRİ-RİS scale, supported by animations. Training videos for blood pressure measurements and medication adherence will be recorded and supervised by local academic nurse practitioners. Data analysis will utilize appropriate statistical tests conducted through computer programs. The project is anticipated to contribute significantly to researcher development, enhance quality of life and disease management, increase productivity, and establish new projects.

Conditions

Hypertension, Essential Hypertension

Keywords

Hypertension; Self-Efficacy; Quality of Life; Mobile Application

Outcome Measures

Primary Outcomes (2)

• SF- 36 Life Quality Scale

  The scale is a multifactor scale that includes thirty-six statements and assesses two main topics (physical and mental dimensions) and eight concepts (physical function, role limitation-physical, pain, vitality/fatigue, social function, role limitation-emotional, mental health, general health perception). A separate score is obtained for each subscale. SF-36 evaluates both negative and positive aspects of health status. The subscale scores vary between 0-100. Each health domain of the SF-36 with positive scoring in the scale is scored in such a way that the higher the score of each health domain, the higher the health-related quality of life.

  up to three months

• Hypertension Self-Efficacy Scale

  The scale consists of 20 items. In the original scale, the items are in 4-point Likert type ranging from "not at all appropriate" (1 point) to "very appropriate" (4 points). The total score of the scale varies between 20-80 points. An increase in the total score obtained from the scale indicates an increase in the level of self-efficacy in hypertension.

  up to three months

Secondary Outcomes (1)

• International Physical Activity Scale-Short Form

  up to three months

Study Arms (2)

Intervention Group

EXPERIMENTAL

mobile application

Other: mobile application

Control Group

NO INTERVENTION

Control Group

Interventions

mobile application OTHER

mobile application for diet, exercises and medication adherence

Intervention Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old Being open to communication and co-operation Having and using a smartphone Agreeing to follow a personalised diet programme Taking antihypertensive medication

You may not qualify if:

• Illiteracy Having had MI within the last month, heart failure, valvular heart disease, exertional dyspnoea, chronic kidney disease visual problems (to be obtained from ASM records). Having a history of a disease that may cause memory impairment such as dementia, Alzheimers disease (to be obtained from ASM records).
• Presence of an orthopaedic and/or neurological problem that may prevent participation in exercise

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University

Malatya, 44280, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Fidan BALKAYA, PhD student

CONTACT

+905454709480; fidan.balkaya@inonu.edu.tr

Rukuye AYLAZ, PhD

CONTACT

+905352289084; rukuye.aylaz@inonu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be determined blindly by being assigned by a site.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asistant

Model Details: Our study has two groups of 78 participants each. Our study is an experimental study with pretest-posttest control group.

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 20, 2024
• Study Start: April 30, 2024
• Primary Completion: November 30, 2024
• Study Completion: January 30, 2026
• Last Updated: September 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)