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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05476120
Other study ID # Duygu ATALI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date April 30, 2021

Study information

Verified date July 2022
Source Dokuz Eylul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The research is planned to evaluate the treatment compliance after the BATHE interview technique in hypertension patients.


Description:

In order to be evaluated for suitability for the study, patients aged 18-80 who have been diagnosed with hypertension for at least 6 months (n= 220) were interviewed and 86 hypertension patients who met the inclusion criteria and volunteered for the study were included in the study. Participants whose eligibility was determined as a result of the evaluation in terms of inclusion and exclusion criteria were asked about their volunteerism in the intervention study, their written consent was obtained from those who volunteered, and those who volunteered were randomized.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date April 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Being a patient of hypertension - Be over 18 years old - Be less than 80 years old - To have been diagnosed for at least 6 months - Volunteering - To be able to use any of the online video calling channels Exclusion Criteria: - Communication problem - Presence of psychiatric illness and/or use of psychiatric medication - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
BATHE
The BATHE interview technique was applied 3 times, once every 3 months, for 6 months.

Locations

Country Name City State
Turkey Vildan MEVSIM Izmir Balçova

Sponsors (1)

Lead Sponsor Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Scale for Evaluating the Success of Treatment Adherence and Lifestyle Change in Hypertensive Individuals The scale consists of 18 questions. The questions were structured in a positive and negative way and the answers were expressed as a five-point likert. The contents of the questions were prepared to enlighten the subjects of medical treatment and clinical controls, communication with the physician, active lifestyle and physical activity, weight control, healthy nutrition and salt consumption, and disease awareness. After reverse scoring, if all items are given 5 points, the highest total score that can be obtained from the scale is 90. When all items are given 1 point, the lowest score that can be obtained from the scale is 18. The scale cutoff point is 68. A score of less than 68 indicates low adherence to treatment, and a score of 68 and above indicates high adherence to treatment. An increase in the score on the scale indicates an increase in treatment compliance. Baseline and sixth month
Primary Turkish Modified Morisky Scale The scale consists of 6 questions. The questions were answered as Yes/No and in the evaluation; in questions 2 and 5 yes 1 point, no 0 points; In other questions, yes is 0 points, no is 1 point. If the total score obtained by the patient in questions 1, 2 and 6 is 0 or 1, it indicates low motivation level, and >1 indicates high motivation level. If the total score from questions 3, 4 and 5 is 0 or 1, it indicates low level of knowledge, and >1 indicates high level of knowledge. Baseline and sixth month
Secondary Waist circumference At the beginning and at the 6th month, the waist circumference of the participants was measured by the researcher under appropriate conditions and in both interviews. Baseline and sixth month
Secondary BMI At the beginning and at the 6th month, BMI of the participants was measured by the researcher under appropriate conditions and in both interviews. Baseline and sixth month
Secondary Blood pressure In both interviews, both systolic and diastolic blood pressures of the participants were measured by the researcher under appropriate conditions and at 6 months. Baseline and sixth month
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