Hypertension PatientsNCT05060575
Hypertension Patients on Drug Medication Adherence and Rational Medication Use
A study testing Education and Telephone Counceling in people with Hypertension Patients, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension Patients
- What is being tested?
- Education and Telephone Counceling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 1 Jun 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - 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,
Show all 9Show fewer
- Owns a phone
- Open to communication and cooperation,
- Patients willing to participate in the study will be included in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacer GÖK UĞUR
Ordu, Cumhuriyet Campus Cumhuriyet District, 52200
About this study
Official title: The Effect of Education and Telephone Counseling Given to Hypertension Patients on Drug Medıcation Adherence and Rational Medication Use: Single-Blind Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Hypertension Patients
- Being tested
- Education and Telephone Counceling
- Keywords
- Hypertension, Tele nursing, Education, Rational medication use, Drug medication adherence, Nursing
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and Telephone CouncelingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| EDUTC | Experimental | 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. Receives: Other: Education and Telephone Counceling |
| Control Group | Active comparator | Routine hospital care. Receives: Other: Education and Telephone Counceling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Medication Self-Efficacy Scale
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.
Measured: 12 weeks
Rational Drug Use Scale
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.
Measured: 12 weeks
Secondary outcomes (1)
Diastolic/Systolic blood pressure
Systolic and Diastolic blood pressure will be measured.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start1 Oct 2021
- Primary completion1 May 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension PatientsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacer Gok Ugur, Ordu University
- Investigators
- Hacer GÖK UĞUR, Assoc., Principal investigator, Ordu Ünivercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060575
- Sponsor's protocol ID
- ayyuzlum3207
- Status last verified
- Oct 2022
- First submitted
- 18 Sep 2021
- Last updated
- 18 Oct 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 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education and Telephone Counseling Given to Hypertension Patients on Drug Medıcation Adherence and Rational Medication Use: Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05060575
- Acronym / sponsor ID
- ayyuzlum3207
- Conditions
- Hypertension Patients
- Keywords
- Hypertension, Tele nursing, Education, Rational medication use, Drug medication adherence, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 29 Sep 2021 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EDUTC | Experimental | Other: Education and Telephone CouncelingDrug 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. |
| Control Group | Active comparator | Other: Education and Telephone CouncelingRoutine hospital care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- - 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,
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Education and Telephone CouncelingDrug 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. | Other | Control Group, EDUTC |
Primary outcome
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.
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.
1 secondary outcome
Diastolic/Systolic blood pressure
Time frame: 12 weeks
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 18 Oct 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.
Hacer GÖK UĞUR, Assoc. principal investigator
Ordu Ünivercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Telephone Counceling in people with Hypertension Patients, run by Ordu 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 9 inclusion and 4 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 18 Oct 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?
Adherence to Medication Self-Efficacy Scale (time frame: 12 weeks). 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 18 Oct 2022.