- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05060575
Hypertension Patients on Drug Medication Adherence and Rational Medication Use
The Effect of Education and Telephone Counseling Given to Hypertension Patients on Drug Medıcation Adherence and Rational Medication Use: Single-Blind Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This research will be conducted to determine the effects of education and telephone counseling given to hypertension patients on drug treatment compliance and rational drug use.
Research Hypotheses H0: Education and telephone counseling given to hypertension patients do not affect drug treatment compliance.
H1: Education and telephone counseling given to hypertension patients increase drug treatment compliance.
H0: Education and telephone counseling given to hypertension patients do not affect rational drug use.
H1: Education and telephone counseling given to hypertension patients increase rational drug use.
This study was planned as a single-blind randomized controlled experimental study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cumhuriyet Campus Cumhuriyet District
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Ordu, Cumhuriyet Campus Cumhuriyet District, Turkey, 52200
- Hacer GÖK UĞUR
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- - Diagnosed with hypertension,
- Hypertension disease duration of at least 6 months,
- Using at least one drug due to hypertension,
- 18 years old and over
- Literate,
- Living in the town centre,
- Owns a phone
- Open to communication and cooperation,
- Patients willing to participate in the study will be included in the study.
Exclusion Criteria:
- Having a psychiatric illness
- Hearing loss,
- Can't understand or speak Turkish and
- Patients who do not wish to continue the study will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: EDUTC
Drug use and rational drug use training will be given to hypertension patients in the experimental group. The patients in the experimental group twice in the 1st month (2nd and 4th weeks), once in the 2nd month (8th week) and once in the 3rd month (12th week) phone call counseling will be providedved an average of 10-15 minutes. |
Drug use and rational drug use training will be given to hypertension patients in the experimental group. The patients in the experimental group twice in the 1st month (2nd and 4th weeks), once in the 2nd month (8th week) and once in the 3rd month (12th week) phone call counseling will be providedved an average of 10-15 minutes. |
ACTIVE_COMPARATOR: Control Group
Routine hospital care.
|
Drug use and rational drug use training will be given to hypertension patients in the experimental group. The patients in the experimental group twice in the 1st month (2nd and 4th weeks), once in the 2nd month (8th week) and once in the 3rd month (12th week) phone call counseling will be providedved an average of 10-15 minutes. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to Medication Self-Efficacy Scale
Time Frame: 12 weeks
|
The scale consists of 13 items and determines the self-efficacy/confidence level of adherence to drug treatments of individuals with hypertension.
The scale is evaluated by scoring from 1 to 4 in each question.
The minimum score that can be obtained from the scale is 13, and the maximum score is 52.
The increase in the scale score indicates that the compliance of individuals to antihypertensive drug treatment increases positively.
|
12 weeks
|
Rational Drug Use Scale
Time Frame: 12 weeks
|
The scale has 36 items and is a triple Likert type.
Behavioral beliefs (items 1-9), Control beliefs (items 10-16), Attitude (items 17-21), Subjective norm (items 22-23), Intention (items 24-28), and Knowledge It has 6 sub-dimensions (items between 29 and 36).
Scoring of scale items was never (0), sometimes (1), and always (2) for positive items; negative items (items 13, 14, 17, 18, 19, 20, 21, and 24) are calculated as never (2), sometimes (1), and always (0).
The scores that can be obtained from the scale range from 0 to 72.
As the score obtained from the scale increases, the level of rational drug use increases.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diastolic/Systolic blood pressure
Time Frame: 12 weeks
|
Systolic and Diastolic blood pressure will be measured.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hacer GÖK UĞUR, Assoc., Ordu Univercity
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ayyuzlum3207
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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