- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05392140
The Effect of Smart Phone Application Supported Nursing Care Program
May 23, 2022 updated by: Zeynep Arabacı, Kastamonu University
The Effect of Smart Phone Application Supported Nursing Care Program on the Self-Management of Hypertensive Patients
Hypertension is an important public health problem in our country and in the world.
For success in hypertension treatment, timely and accurate diagnosis of patients, effective implementation of lifestyle changes, timely initiation of drug therapy and effective drug compliance are emphasized.
The rapid adoption of smartphone technology provides a promising platform for overcoming drug non-compliance by providing medication intake reminders, healthy lifestyle education.
It is emphasized that the health belief model can be used in the self-management of the hypertension patient's health and in the regulation of services with smart phone applications.
Based on these facts, this study was planned to examine the effect of the smart phone management system supported nursing care program given by the nurse to the primary hypertension patients registered in the Family Health Center on the patient's compliance with the treatment and the blood pressure staying within the target limits.
The research was organized in an experimental design with pre-test post-test control group.
The population of the research consists of primary hypertensive patients registered in Family Health Centers in Tosya district of Kastamonu province.
It is planned to include a total of 102 people, 51 in the intervention and control groups, in the sample group.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Hypertension is an important public health problem in our country and in the world.
For success in hypertension treatment, timely and accurate diagnosis of patients, effective implementation of lifestyle changes, timely initiation of drug therapy and effective drug compliance are emphasized.
The rapid adoption of smartphone technology provides a promising platform for overcoming drug non-compliance by providing medication intake reminders, healthy lifestyle education.
It is emphasized that the health belief model can be used in the self-management of the hypertension patient's health and in the regulation of services with smart phone applications.
Based on these facts, this study was planned to examine the effect of the smart phone management system supported nursing care program given by the nurse to the primary hypertension patients registered in the Family Health Center on the patient's compliance with the treatment and the blood pressure staying within the target limits.
The research was organized in an experimental design with pre-test post-test control group.
The population of the research consists of primary hypertensive patients registered in Family Health Centers in Tosya district of Kastamonu province.
Sample, effect size 0.25; By taking the alpha value of 0.05 and the power of 0.80, the minimum number of samples was calculated as 82.
Considering that there may be data losses, it is planned to include a total of 102 people, 51 in the intervention and control groups, in the sample group.
In data collection, the "Patient Information Form", "Blood pressure follow-up form" prepared by the researcher, and the adaptation to Turkish will be collected with the help of the "Drug Adherence/Compliance Self-Efficacy Scale" prepared by Gözüm and Hacıhasanoğlu in 2005.
Health belief model-based smartphone-assisted nursing care program application will be installed on the phones of the patients who will be in the intervention group.
After the application is started to be used, patients will be notified every two weeks for six months for the disease management process to have nutrition, exercise and doctor control processes.
Patients will be able to send a message to the nurse through the application.
Messages will be answered regularly on a designated day each week.
The data will be collected by face-to-face interview method after necessary explanations and necessary consents are obtained by the researchers.
One month after the posttest application (second data), application predicate and usage, the third data (1st follow-up) will be collected in the 3rd month, the fourth data (2nd follow-up) will be collected in the 6th month.
Study Type
Interventional
Enrollment (Anticipated)
102
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 Contact
- Name: Zeynep ARABACI
- Phone Number: 03662802259
- Email: arabacizeynep@hotmail.com
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
45 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- -Agreeing to participate in the research.
- Being between 45-64 years old
- At least primary school graduate
- Using antihypertensive medication for at least 6 months with the diagnosis of primary (essential) hypertension.
- Owning a smart phone
Exclusion Criteria:
- Being diagnosed with secondary hypertension Have been diagnosed with pregnancy-onset hypertension
- Hearing, seeing and understanding problems Having a diagnosis of dementia and alzheimer's
- Diagnosed with chronic kidney failure
- Being a dialysis patient
- History of myocardial infarction, stroke, diagnosis of heart failure
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: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention group.
Health belief model-based smartphone-assisted nursing care program application will be installed on the phones of the patients who will be in the intervention group.
|
Health belief model-based smartphone-assisted nursing care program application will be installed on the phones of the patients who will be in the intervention group.
|
|
Active Comparator: non-intervention group
standard care practice will continue
|
Standart care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
There is a difference in time (pre-test, after intervention, 1st month, 3rd month, 6th month) between intervention and control group patients' self-efficacy scale scores of adherence to drug therapy.
Time Frame: 0-6 month
|
Drug Adherence/Compliance Self-Efficacy Scale
|
0-6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
There is a difference in time (pre-test, after the intervention, 1st month, 3rd month, 6th month) between the patients in the intervention and control groups having normal systolic and diastolic blood pressure measurements.
Time Frame: 0-6 month
|
Blood pressure follow-up form
|
0-6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Zeynep ARABACI, Kastamonu University
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 (Anticipated)
May 25, 2022
Primary Completion (Anticipated)
November 25, 2022
Study Completion (Anticipated)
December 30, 2022
Study Registration Dates
First Submitted
May 23, 2022
First Submitted That Met QC Criteria
May 23, 2022
First Posted (Actual)
May 26, 2022
Study Record Updates
Last Update Posted (Actual)
May 26, 2022
Last Update Submitted That Met QC Criteria
May 23, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- no sponsors
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
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
Franz Rischard, DOAcceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway...Not yet recruitingPulmonary Hypertension | Pulmonary Arterial Hypertension (PAH)United States
-
Abant Izzet Baysal UniversityNot yet recruitingPRIMARY HYPERTENSIONTurkey (Türkiye)
-
SingHealth PolyclinicsNanyang PolytechnicEnrolling by invitationHypertension,EssentialSingapore
-
Hacettepe UniversityBozok UniversityCompletedHypertension | Arterial Hypertension | Systemic HypertensionTurkey (Türkiye)
-
BackBeat Medical IncNot yet recruitingHypertension, Systolic | Hypertension (HTN) | Heart Failure With Preserved Ejection Fraction (HFpEFGeorgia
-
Xuanwu Hospital, BeijingNot yet recruiting
-
Shenzhen Salubris Pharmaceuticals Co., Ltd.Not yet recruiting
-
Instituto de Cardiologia do Rio Grande do SulCompletedHypertension (HTN) | Hypertension ArterialBrazil
Clinical Trials on Health belief model-based smartphone-assisted nursing care program application will be installed on the phones of the patients who will be in the intervention group.
-
King Saud UniversityCompletedHealth Literacy | Fall Prevention | Chronic Stroke Patients | Education of Patients | Health Belief ModelSaudi Arabia
-
Istanbul University - CerrahpasaRecruiting
-
Memorial Sloan Kettering Cancer CenterCompleted