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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
Kastamonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring Nursing, Medication adherence, Hypertension

Eligibility Criteria

45 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 23, 2022
    Last Updated
    May 23, 2022
    Sponsor
    Kastamonu University
    Collaborators
    Ege University
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    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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