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The Effect of the Use of BATHE Interview Technique on Treatment Compliance in Hypertension Patients in Primary Care

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
BATHE
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Essential Hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vildan MEVSİM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

BATHE

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
November 14, 2021
Last Updated
July 26, 2022
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT05476120
Brief Title
The Effect of the Use of BATHE Interview Technique on Treatment Compliance in Hypertension Patients in Primary Care
Official Title
The Effect of the Use of BATHE Interview Technique on Treatment Compliance in Hypertension Patients in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single-blind, parallel-group, randomized-controlled intervention study
Masking
Participant
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BATHE
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BATHE
Intervention Description
The BATHE interview technique was applied 3 times, once every 3 months, for 6 months.
Primary Outcome Measure Information:
Title
The Scale for Evaluating the Success of Treatment Adherence and Lifestyle Change in Hypertensive Individuals
Description
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.
Time Frame
Baseline and sixth month
Title
Turkish Modified Morisky Scale
Description
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.
Time Frame
Baseline and sixth month
Secondary Outcome Measure Information:
Title
Waist circumference
Description
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.
Time Frame
Baseline and sixth month
Title
BMI
Description
At the beginning and at the 6th month, BMI of the participants was measured by the researcher under appropriate conditions and in both interviews.
Time Frame
Baseline and sixth month
Title
Blood pressure
Description
In both interviews, both systolic and diastolic blood pressures of the participants were measured by the researcher under appropriate conditions and at 6 months.
Time Frame
Baseline and sixth month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Vildan MEVSİM
City
İzmir
State/Province
Balçova
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of the Use of BATHE Interview Technique on Treatment Compliance in Hypertension Patients in Primary Care

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