The Effect of Smart Phone Application Supported Nursing Care Program
Primary Purpose
Hypertension
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
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.
Standart care
Sponsored by

About this trial
This is an interventional prevention trial for Hypertension focused on measuring Nursing, Medication adherence, Hypertension
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
intervention group.
non-intervention group
Arm Description
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.
standard care practice will continue
Outcomes
Primary Outcome Measures
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.
Drug Adherence/Compliance Self-Efficacy Scale
Secondary Outcome Measures
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.
Blood pressure follow-up form
Full Information
NCT ID
NCT05392140
First Posted
May 23, 2022
Last Updated
May 23, 2022
Sponsor
Kastamonu University
Collaborators
Ege University
1. Study Identification
Unique Protocol Identification Number
NCT05392140
Brief Title
The Effect of Smart Phone Application Supported Nursing Care Program
Official Title
The Effect of Smart Phone Application Supported Nursing Care Program on the Self-Management of Hypertensive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 25, 2022 (Anticipated)
Primary Completion Date
November 25, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kastamonu University
Collaborators
Ege University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Nursing, Medication adherence, Hypertension
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The research was organized in an experimental design with pre-test post-test control group.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention group.
Arm Type
Experimental
Arm Description
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.
Arm Title
non-intervention group
Arm Type
Active Comparator
Arm Description
standard care practice will continue
Intervention Type
Behavioral
Intervention Name(s)
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.
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standart care
Intervention Description
Standart care
Primary Outcome Measure Information:
Title
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.
Description
Drug Adherence/Compliance Self-Efficacy Scale
Time Frame
0-6 month
Secondary Outcome Measure Information:
Title
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.
Description
Blood pressure follow-up form
Time Frame
0-6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeynep ARABACI
Phone
03662802259
Email
arabacizeynep@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeynep ARABACI
Organizational Affiliation
Kastamonu University
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Smart Phone Application Supported Nursing Care Program
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