NCT06065085

Brief Summary

This study was planned as randomized controlled trial in order to evaluate the effect of the mobile education given to the individuals with hypertension on DASH diet compliance, healthy lifestyle behaviours, quality of life, mindfulness and stress levels. The study was conducted as a randomized controlled trial with 134 individuals with hypertension (68 experimental, 66 controlled) who applied a university hospital in Edirne between the dates on 20.01.2022 and 18.05.2023. The data were collected by "Patient Information Form", "Healthy Lifestyle Behaviour Scale II", "EQ-5D General Quality of Life Scale", "Mindful Attention Awareness Scale" and "Percieved Stress Scale" were used. An education application was installed on the mobile phones of the experimental group. Individuals with hypertension were provided with a training for three months through the mobile application. Data collection forms were filled in by the individuals with hypertension in the experimental and controlled groups at the beginning and at the 3rd month via the mobile application. The data were analyzed in SPSS 26 (Statistical Package for the Social Sciences) program with the Shapiro-Wilk test, Student's t-test, Paired-Sample t-test, Chi-Square test, Fisher's Exact test, Fisher-Freeman-Halton test and Pearson correlation coefficient. The results were evaluated at % 95 confidence interval and the significance was evaluated at p\<0,05 level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 20, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 18, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 3, 2023

Completed
Last Updated

October 3, 2023

Status Verified

September 1, 2023

Enrollment Period

1.3 years

First QC Date

September 18, 2023

Last Update Submit

September 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mobile Education

    The education given to individuals with hypertension via mobile phone was evaluated with healthy lifestyle behaviors, quality of life, stress and awareness scales.

    three months

Secondary Outcomes (1)

  • Healty Lifestyle Behaviour

    three months

Other Outcomes (3)

  • Quality of Life (EQ-5D General Quality of Life Scale)

    three months

  • Stress

    three months

  • Mindfulness

    three months

Study Arms (1)

Mobile Education

EXPERIMENTAL

An education application was installed on the mobile phones of the experimental group. Individuals with hypertension were provided with a training for three months through the mobile application. Data collection forms were filled in by the individuals with hypertension in the experimental and controlled groups at the beginning and at the 3rd month via the mobile application.

Other: mobile education

Interventions

The study was conducted as a randomized controlled trial with 134 individuals with hypertension (68 experimental, 66 controlled) who applied a university hospital. The data were collected by "Patient Information Form", "Healthy Lifestyle Behaviour Scale II", "EQ-5D General Quality of Life Scale", "Mindful Attention Awareness Scale" and "Percieved Stress Scale" were used. An education application was installed on the mobile phones of the experimental group. Individuals with hypertension were provided with a training for three months through the mobile application. Data collection forms were filled in by the individuals with hypertension in the experimental and controlled groups at the beginning and at the 3rd month via the mobile application.

Mobile Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those diagnosed with Primary Hypertension (at least 1 month ago),
  • Over 18 years,
  • No communication barriers,
  • Being literate,
  • Volunteering to participate in the research,
  • Individuals with hypertension who own a smartphone.

You may not qualify if:

  • under 18 years old,
  • Having a communication barrier,
  • Those with chronic kidney disease,
  • Individuals with hypertension and heart failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya Üniversitesi

Edirne, Merkez, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD. Registered Nurse

Study Record Dates

First Submitted

September 18, 2023

First Posted

October 3, 2023

Study Start

January 20, 2022

Primary Completion

May 18, 2023

Study Completion

August 10, 2023

Last Updated

October 3, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

It will be shared with the participants after it becomes published.

Locations