NCT05476120

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2021

Completed
9 months until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

November 14, 2021

Last Update Submit

July 26, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Waist circumference

    Baseline and sixth month

  • BMI

    Baseline and sixth month

  • Blood pressure

    Baseline and sixth month

Study Arms (2)

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.

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.

Interventions

BATHEBEHAVIORAL

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

BATHE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Communication problem
  • Presence of psychiatric illness and/or use of psychiatric medication
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vildan MEVSİM

Izmir, Balçova, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: single-blind, parallel-group, randomized-controlled intervention study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr.

Study Record Dates

First Submitted

November 14, 2021

First Posted

July 27, 2022

Study Start

October 1, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

July 27, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations