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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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
Behavioral: Standart care
Standart care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kastamonu University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ege University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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