- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05476120
The Effect of the Use of BATHE Interview Technique on Treatment Compliance in Hypertension Patients in Primary Care
July 26, 2022 updated by: Vildan Mevsim, Dokuz Eylul University
The research is planned to evaluate the treatment compliance after the BATHE interview technique in hypertension patients.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
2
Phase
- 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 Locations
-
-
Balçova
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İzmir, Balçova, Turkey
- Vildan MEVSİM
-
-
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
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BATHE
In each interview, the intervention group was intervened by the physician to increase compliance with the treatment using the BATHE technique, and brief information was given emphasizing the importance of drug compliance and lifestyle changes routinely applied by the Family Medicine Department in hypertension patients.
The patients in the intervention group were interviewed face-to-face at the 0th and 6th months, and online at the 3rd month.
|
The BATHE interview technique was applied 3 times, once every 3 months, for 6 months.
|
|
No Intervention: Control
In the control group, brief information was given at each interview, emphasizing the importance of drug compliance and lifestyle changes routinely applied by the Department of Family Medicine in hypertension patients.
No intervention was made.
The patients in the control group were interviewed face-to-face at 0 and 6 months, and online at 3 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Scale for Evaluating the Success of Treatment Adherence and Lifestyle Change in Hypertensive Individuals
Time Frame: Baseline and sixth month
|
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
|
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Turkish Modified Morisky Scale
Time Frame: Baseline and sixth month
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Waist circumference
Time Frame: Baseline and sixth month
|
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.
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Baseline and sixth month
|
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BMI
Time Frame: Baseline and sixth month
|
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
|
|
Blood pressure
Time Frame: Baseline and sixth month
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
October 1, 2020
Primary Completion (Actual)
April 30, 2021
Study Completion (Actual)
April 30, 2021
Study Registration Dates
First Submitted
November 14, 2021
First Submitted That Met QC Criteria
July 26, 2022
First Posted (Actual)
July 27, 2022
Study Record Updates
Last Update Posted (Actual)
July 27, 2022
Last Update Submitted That Met QC Criteria
July 26, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Duygu ATALI
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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