NCT05392140

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable hypertension

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

May 25, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

May 23, 2022

Last Update Submit

May 23, 2022

Conditions

Keywords

Nursing, Medication adherence, Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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

    0-6 month

Secondary Outcomes (1)

  • 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.

    0-6 month

Study Arms (2)

intervention group.

EXPERIMENTAL

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.

non-intervention group

ACTIVE COMPARATOR

standard care practice will continue

Behavioral: Standart care

Interventions

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 group.
Standart careBEHAVIORAL

Standart care

non-intervention group

Eligibility Criteria

Age45 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionMedication Adherence

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Zeynep ARABACI

    Kastamonu University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: The research was organized in an experimental design with pre-test post-test control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 26, 2022

Study Start

May 25, 2022

Primary Completion

November 25, 2022

Study Completion

December 30, 2022

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share