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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06065085
Other study ID # 2021/128
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 20, 2022
Est. completion date August 10, 2023

Study information

Verified date September 2023
Source Trakya University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 134
Est. completion date August 10, 2023
Est. primary completion date May 18, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - under 18 years old, - Having a communication barrier, - Those with chronic kidney disease, - Individuals with hypertension and heart failure.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
mobile education
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.

Locations

Country Name City State
Turkey Trakya Üniversitesi Edirne Merkez

Sponsors (1)

Lead Sponsor Collaborator
Trakya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Quality of Life (EQ-5D General Quality of Life Scale) The education given to individuals with hypertension via mobile phone was evaluated with EQ-5D General Quality of Life Scale. three months
Other Stress The education given to individuals with hypertension via mobile phone was evaluated with Percieved Stress Scale . three months
Other Mindfulness The education given to individuals with hypertension via mobile phone was evaluated with Mindful Attention Awareness Scale. three months
Primary 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 Healty Lifestyle Behaviour The education given to individuals with hypertension via mobile phone was evaluated with the healthy lifestyle behaviors scale II. three months
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