Essential HypertensionNCT05476120
The Effect of the Use of BATHE Interview Technique on Treatment Compliance in Hypertension Patients in Primary Care
A study testing BATHE in people with Essential Hypertension, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The research is planned to evaluate the treatment compliance after the BATHE interview technique in hypertension patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- BATHE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Communication problem
- Presence of psychiatric illness and/or use of psychiatric medication
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The research is planned to evaluate the treatment compliance after the BATHE interview technique in hypertension patients.
Read the 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.
- Conditions
- Essential Hypertension
- Being tested
- BATHE
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BATHEBehavioural
The BATHE interview technique was applied 3 times, once every 3 months, for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| BATHE | Experimental | 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. Receives: Behavioral: BATHE |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and sixth month
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.
Measured: Baseline and sixth month
Secondary outcomes (3)
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.
Measured: Baseline and sixth month
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.
Measured: Baseline and sixth month
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.
Measured: Baseline and sixth month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 Oct 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-blind, parallel-group, randomized-controlled intervention study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vildan Mevsim, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476120
- Sponsor's protocol ID
- Duygu ATALI
- Status last verified
- Jul 2022
- First submitted
- 14 Nov 2021
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Use of BATHE Interview Technique on Treatment Compliance in Hypertension Patients in Primary Care
- ClinicalTrials.gov ID
- NCT05476120
- Acronym / sponsor ID
- Duygu ATALI
- Conditions
- Essential Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- single-blind, parallel-group, randomized-controlled intervention study
| Arm | Type | Receives |
|---|---|---|
| BATHE | Experimental | Behavioral: BATHEIn 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Communication problem
- Presence of psychiatric illness and/or use of psychiatric medication
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BATHEThe BATHE interview technique was applied 3 times, once every 3 months, for 6 months. | Behavioural | BATHE |
Primary outcome
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.
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.
3 secondary outcomes
Waist circumference
Time frame: Baseline and sixth month
BMI
Time frame: Baseline and sixth month
Blood pressure
Time frame: Baseline and sixth month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BATHE in people with Essential Hypertension, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Scale for Evaluating the Success of Treatment Adherence and Lifestyle Change in Hypertensive Individuals (time frame: Baseline and sixth month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.