HypertensionNCT05316454
Self-Efficacy Support on Medication Adherence and Self-Efficacy Levels in Hypertension Patients
A study testing self-efficacy support in people with Hypertension, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Background:Health professionals are responsible for the education of hypertension patients. Aim:The aim of this research is to see how self-efficacy support affects hypertension patients' medication adherence and self-efficacy levels. Methods: This research is randomized controlled interventional research. Read more about this study
- Who is it for?
- Ages 50 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- self-efficacy support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 1 Feb 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 50 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All intervention and control groups were required to meet the inclusion criteria below.
- With a diagnosis of essential hypertension, follow up for at least 6 months,
- Using antihypertensive drugs,
- Not changing the antihypertensive medication in the last 1 month,
- Not having mental or communication problems,
- Being the age of 18 or older,
- Having at least primary education level,
- Not being a pregnant or nursing mother.
Who cannot join
- All intervention and control groups were required to meet the inclusion criteria below.
- With a diagnosis of essential hypertension, follow up for at least 6 months,
- Using antihypertensive drugs,
- Not changing the antihypertensive medication in the last 1 month,
- Not having mental or communication problems,
- Being the age of 18 or older,
- Having at least primary education level,
- Not being a pregnant or nursing mother.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk University Faculty of Nursing
Erzurum, Center, 25242
About this study
Official title: Effect of Self-Efficacy Support on Medication Adherence and Self-Efficacy Levels in Hypertension Patients: A Randomized Controlled Trial
Background:Health professionals are responsible for the education of hypertension patients.
Aim:The aim of this research is to see how self-efficacy support affects hypertension patients' medication adherence and self-efficacy levels.
Methods: This research is randomized controlled interventional research. The research is conducted inTurkey June-December2021.The research sample included 63hypertension patients who met the research's research requirements.According to the sequence of the arrival at the hospital, data were separated into groups with odd(intervention group)and double(control group)numbers.The necessary forms for both groups' pre-test data were filled out face-to-face. The intervention group received hands-on blood pressure measurement training with the "Hypertension Training Manual",including how to self-measure blood pressure.Over the course of the research, patients were asked to check their blood pressure twice a day at home and record the results.The patients in the intervention group were reminded of their blood pressure measurement three times a week by SMStechnique for three months to avoid forgetting it.Three months later, the same forms for the post-test data of both groups were filled out with an online survey method.The data were evaluated using the single-blind study.
Read the detailed description
Background:Health professionals are responsible for the education of hypertension patients.
Aim:The aim of this research is to see how self-efficacy support affects hypertension patients' medication adherence and self-efficacy levels.
The Research's Population and Sample Hypertension patients who applied to the cardiology outpatient clinics at a Hospital in Turkey between June and December 2021 formed the target population of the research. The research sample included 63 hypertension patients over the age of 18 who met the research requirements and agreed to participate.
A priori power analysis was used to determine the sample size, and it was determined that each of the intervention and control groups needed at least 30 hypertension patients for the research's power to exceed 80% at the 95% confidence interval, 0.05 significance level, and medium effect size. Given the possibility of data loss owing to a variety of factors, it was decided to include 100 hypertension patients in the research sample. Because 12 patients wished to withdraw from the research and 25 patients did not complete the final applications, the research sample consisted of 63 hypertension patients, 31 in the intervention group and 32 in the control group.
Criteria for Research Inclusion All intervention and control groups were required to meet the inclusion criteria below.
- With a diagnosis of essential hypertension, follow up for at least 6 months,
- Using antihypertensive drugs,
- Not changing the antihypertensive medication in the last 1 month,
- Not having mental or communication problems,
- Being the age of 18 or older,
- Having at least primary education level,
- Not being a pregnant or nursing mother. Data Collection Data Collection Tools To Be Used in the Research The research data were collected using the "Patient Descriptive Information Form", "Self-Efficacy-Efficacy Scale", and "Medication Adherence Self-Efficacy-Efficacy Scale in Hypertensive Patients." Patient Introductory Information Form This form, which has been developed by the researchers based on the literature and has 19 questions, includes the socio-demographic characteristics of the patients and their disease-related features.
Self-Efficacy - Efficacy Scale The scale evaluates generic self-efficacy-efficacy perception and does not belong to any subjective category. The Self-Efficacy-Efficacy Scale is a 23-item, 5-point Likert-type scale with a minimum of 23 points and a maximum of 115 points.
Medication Adherence Self-Efficacy Scale in Hypertensive Patients The scale consists of 13 items and is in a four-point Likert type. The scale can be used to determine the lowest 13 and highest 52 points. The increase in the scale score shows that the individuals' compliance with the antihypertensive medication is above average.
Used Materials for Self-Efficacy Support Hypertension Education Booklet The Hypertension Education Booklet, which was created by the researchers based on the literature review, contains information about the disease and its treatment, treatment methods, lifestyle changes that are effective in the management of hypertension, the importance of treatment compliance, and blood pressure measurement at home.
For the booklet, 1 internal medicine specialist, 3 nurse faculty members, and 1 specialist nurse provided expert opinions. In addition, three hypertension patients were given the booklet to assess its comprehension, and arrangements were made based on their ideas. The survey was completed after Item and Content validity analyses were performed.
Blood Pressure Monitor Given the uncertainty of measurement by auscultation, the Hypertension Guidelines in the 2015 Canadian Education Program advocate using an automatic sphygmomanometer for office blood pressure measurement.Blood pressure is now measured at home using an upper arm blood pressure monitor. As a result, an appropriate blood pressure monitor, which enables self-measured blood pressure monitoring at home, with the BAP project number TSA-2021-8985 was delivered within the scope of the project. The device complies with the European Norm EN 60601-1-2.
Phone "Don't forget to measure your blood pressure in the morning and evening!" message sent 3 times a week by SMS method to the patients in the intervention group. In addition, the patients were contacted by phone at the end of the first, second, and third months to acquire information regarding the research process.
Research Implementation The objective of the research and the manner of application was explained to all patients in the intervention and control groups who met the eligibility requirements. Patients who agreed to take part in the research were required to complete an "Informed Consent Form for Volunteers." As a pre-test, both groups were given the "Patient Introductory Information Form","Self-Efficacy-Efficacy Scale", and "Medication Adherence Self-Efficacy Scale in Hypertensive Patients" through a face-to-face interview.
Separation of Groups Patients were sorted into odd and even numbers according to the order in which they arrived at the hospital in the research, regardless of their age or gender, as long as the number of participants in the intervention and control groups was equal. The method was repeated until a total of 100 data points were collected, with odd numbers representing the intervention group and even numbers representing the control group.
Intervention Group Patient education and blood pressure measurement training took place in the ECG room of the outpatient clinic which is equipped to instruct patients. The "Hypertension Education Booklet" was used to instruct the patients. Following that, the patient received blood pressure measurement training, including a demonstration of how to self-measure blood pressure. The patient was instructed to repeat the same process. The researcher provided retraining in the event of errors or shortcomings. The training continued until the patient performed the accurate measurement. It took around half an hour. The patients were given a blood pressure monitor to use at home to test their blood pressure. Patients were asked to take their blood pressure at home twice a day and record the results during the research. Patients in the intervention group were texted three times a week for three months to remind them to take their blood pressure.
The patients were called by phone after the first month to control the procedure and acquire information about the research process. In addition, the patients' queries were answered and information on the various events that occurred was acquired. Similarly, patients were also reached by phone after the second month to control the process and acquire information about the research process. The same forms were given to the patients in the intervention group as a post-test at the end of the third month, utilizing an online survey method.
Control Group The control group received no intervention after the pre-test data of the control group were gathered face to face. The same forms were collected as post-test data via an online survey method at the end of the third month.
Pre-Application The researcher invited two patients who applied to the outpatient clinic to read and answer the survey questions before the research to assess the intelligibility of the questions in the data collection form. All of the questions were found to be clear and of adequate scope. The data of the patients, taken to the pre-application, were not included in the research data.
Data Evaluation The statistics were evaluated using the single-blind study. The data were analyzed in the SPSS 20 Package Program. To establish their distribution among the groups, frequency and percentage distributions were utilized. The intervention and control groups were compared using the chi-square test. To compare two independent groups, an "independent sample t-test" was utilized. To compare two dependent groups, a "Paired t-test" was performed. Descriptive statistics (mean and standard deviation) were used. The statistical significance cut-off value was set at 0.05.
- Conditions
- Hypertension
- Being tested
- self-efficacy support
- Keywords
- Nursing, hypertension, self-efficacy, self-efficacy support
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-efficacy supportBehavioural
self-efficacy support
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients with hypertension benefit from self-efficacy support in terms of medication adherence and self-efficacy. Receives: Behavioral: self-efficacy support |
| Control | No intervention | No change. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Efficacy - Efficacy Scale
The scale evaluates generic self-efficacy-efficacy perception and does not belong to any subjective category. The Self-Efficacy-Efficacy Scale is a 23-item, 5-point Likert-type scale with a minimum of 23 points and a maximum of 115 points.
Measured: 3months
Medication Adherence Self-Efficacy Scale in Hypertensive Patients
The scale consists of 13 items and is in a four-point Likert type. The scale can be used to determine the lowest 13 and highest 52 points. The increase in the scale score shows that the individuals' compliance with the antihypertensive medication is above average.
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Jun 2021
- Primary completion1 Sep 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahar Ciftci, Ataturk University
- Investigators
- BAHAR Çiftçi, phd, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316454
- Sponsor's protocol ID
- B.30.2.ATA.. 0.01.00/
- Status last verified
- Mar 2022
- First submitted
- 21 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The article is intented to be shared after it is published.
Publications
Erden Y, Yildiz GN, Ciftci B, Avsar G, Ozek S, Ozbek E, Sarialioglu A. The effect of self-management program with tele-nursing based on the Roper-Logan-Tierney model on self-care of hypertensive patients: a randomized controlled trial. BMC Nurs. 2025 Mar 25;24(1):313. doi: 10.1186/s12912-025-02854-y.
PubMed 40133854
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Self-Efficacy Support on Medication Adherence and Self-Efficacy Levels in Hypertension Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05316454
- Acronym / sponsor ID
- B.30.2.ATA.. 0.01.00/
- Conditions
- Hypertension
- Keywords
- Nursing, hypertension, self-efficacy, self-efficacy support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 7 Apr 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.
Background:Health professionals are responsible for the education of hypertension patients.
Aim:The aim of this research is to see how self-efficacy support affects hypertension patients' medication adherence and self-efficacy levels.
Methods: This research is randomized controlled interventional research. The research is conducted inTurkey June-December2021.The research sample included 63hypertension patients who met the research's research requirements.According to the sequence of the arrival at the hospital, data were separated into groups with odd(intervention group)and double(control group)numbers.The necessary forms for both groups' pre-test data were filled out face-to-face. The intervention group received hands-on blood pressure measurement training with the "Hypertension Training Manual",including how to self-measure blood pressure.Over the course of the research, patients were asked to check their blood pressure twice a day at home and record the results.The patients in the intervention group were reminded of their blood pressure measurement three times a week by SMStechnique for three months to avoid forgetting it.Three months later, the same forms for the post-test data of both groups were filled out with an online survey method.The data were evaluated using the single-blind study.
Detailed description
Background:Health professionals are responsible for the education of hypertension patients.
Aim:The aim of this research is to see how self-efficacy support affects hypertension patients' medication adherence and self-efficacy levels.
The Research's Population and Sample Hypertension patients who applied to the cardiology outpatient clinics at a Hospital in Turkey between June and December 2021 formed the target population of the research. The research sample included 63 hypertension patients over the age of 18 who met the research requirements and agreed to participate.
A priori power analysis was used to determine the sample size, and it was determined that each of the intervention and control groups needed at least 30 hypertension patients for the research's power to exceed 80% at the 95% confidence interval, 0.05 significance level, and medium effect size. Given the possibility of data loss owing to a variety of factors, it was decided to include 100 hypertension patients in the research sample. Because 12 patients wished to withdraw from the research and 25 patients did not complete the final applications, the research sample consisted of 63 hypertension patients, 31 in the intervention group and 32 in the control group.
Criteria for Research Inclusion All intervention and control groups were required to meet the inclusion criteria below.
- With a diagnosis of essential hypertension, follow up for at least 6 months,
- Using antihypertensive drugs,
- Not changing the antihypertensive medication in the last 1 month,
- Not having mental or communication problems,
- Being the age of 18 or older,
- Having at least primary education level,
- Not being a pregnant or nursing mother. Data Collection Data Collection Tools To Be Used in the Research The research data were collected using the "Patient Descriptive Information Form", "Self-Efficacy-Efficacy Scale", and "Medication Adherence Self-Efficacy-Efficacy Scale in Hypertensive Patients." Patient Introductory Information Form This form, which has been developed by the researchers based on the literature and has 19 questions, includes the socio-demographic characteristics of the patients and their disease-related features.
Self-Efficacy - Efficacy Scale The scale evaluates generic self-efficacy-efficacy perception and does not belong to any subjective category. The Self-Efficacy-Efficacy Scale is a 23-item, 5-point Likert-type scale with a minimum of 23 points and a maximum of 115 points.
Medication Adherence Self-Efficacy Scale in Hypertensive Patients The scale consists of 13 items and is in a four-point Likert type. The scale can be used to determine the lowest 13 and highest 52 points. The increase in the scale score shows that the individuals' compliance with the antihypertensive medication is above average.
Used Materials for Self-Efficacy Support Hypertension Education Booklet The Hypertension Education Booklet, which was created by the researchers based on the literature review, contains information about the disease and its treatment, treatment methods, lifestyle changes that are effective in the management of hypertension, the importance of treatment compliance, and blood pressure measurement at home.
For the booklet, 1 internal medicine specialist, 3 nurse faculty members, and 1 specialist nurse provided expert opinions. In addition, three hypertension patients were given the booklet to assess its comprehension, and arrangements were made based on their ideas. The survey was completed after Item and Content validity analyses were performed.
Blood Pressure Monitor Given the uncertainty of measurement by auscultation, the Hypertension Guidelines in the 2015 Canadian Education Program advocate using an automatic sphygmomanometer for office blood pressure measurement.Blood pressure is now measured at home using an upper arm blood pressure monitor. As a result, an appropriate blood pressure monitor, which enables self-measured blood pressure monitoring at home, with the BAP project number TSA-2021-8985 was delivered within the scope of the project. The device complies with the European Norm EN 60601-1-2.
Phone "Don't forget to measure your blood pressure in the morning and evening!" message sent 3 times a week by SMS method to the patients in the intervention group. In addition, the patients were contacted by phone at the end of the first, second, and third months to acquire information regarding the research process.
Research Implementation The objective of the research and the manner of application was explained to all patients in the intervention and control groups who met the eligibility requirements. Patients who agreed to take part in the research were required to complete an "Informed Consent Form for Volunteers." As a pre-test, both groups were given the "Patient Introductory Information Form","Self-Efficacy-Efficacy Scale", and "Medication Adherence Self-Efficacy Scale in Hypertensive Patients" through a face-to-face interview.
Separation of Groups Patients were sorted into odd and even numbers according to the order in which they arrived at the hospital in the research, regardless of their age or gender, as long as the number of participants in the intervention and control groups was equal. The method was repeated until a total of 100 data points were collected, with odd numbers representing the intervention group and even numbers representing the control group.
Intervention Group Patient education and blood pressure measurement training took place in the ECG room of the outpatient clinic which is equipped to instruct patients. The "Hypertension Education Booklet" was used to instruct the patients. Following that, the patient received blood pressure measurement training, including a demonstration of how to self-measure blood pressure. The patient was instructed to repeat the same process. The researcher provided retraining in the event of errors or shortcomings. The training continued until the patient performed the accurate measurement. It took around half an hour. The patients were given a blood pressure monitor to use at home to test their blood pressure. Patients were asked to take their blood pressure at home twice a day and record the results during the research. Patients in the intervention group were texted three times a week for three months to remind them to take their blood pressure.
The patients were called by phone after the first month to control the procedure and acquire information about the research process. In addition, the patients' queries were answered and information on the various events that occurred was acquired. Similarly, patients were also reached by phone after the second month to control the process and acquire information about the research process. The same forms were given to the patients in the intervention group as a post-test at the end of the third month, utilizing an online survey method.
Control Group The control group received no intervention after the pre-test data of the control group were gathered face to face. The same forms were collected as post-test data via an online survey method at the end of the third month.
Pre-Application The researcher invited two patients who applied to the outpatient clinic to read and answer the survey questions before the research to assess the intelligibility of the questions in the data collection form. All of the questions were found to be clear and of adequate scope. The data of the patients, taken to the pre-application, were not included in the research data.
Data Evaluation The statistics were evaluated using the single-blind study. The data were analyzed in the SPSS 20 Package Program. To establish their distribution among the groups, frequency and percentage distributions were utilized. The intervention and control groups were compared using the chi-square test. To compare two independent groups, an "independent sample t-test" was utilized. To compare two dependent groups, a "Paired t-test" was performed. Descriptive statistics (mean and standard deviation) were used. The statistical significance cut-off value was set at 0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: self-efficacy supportPatients with hypertension benefit from self-efficacy support in terms of medication adherence and self-efficacy. |
| Control | No intervention | –No change. |
Who may qualify
- Ages
- 50 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All intervention and control groups were required to meet the inclusion criteria below.
- With a diagnosis of essential hypertension, follow up for at least 6 months,
- Using antihypertensive drugs,
- Not changing the antihypertensive medication in the last 1 month,
- Not having mental or communication problems,
Key exclusion criteria (8 listed)
- All intervention and control groups were required to meet the inclusion criteria below.
- With a diagnosis of essential hypertension, follow up for at least 6 months,
- Using antihypertensive drugs,
- Not changing the antihypertensive medication in the last 1 month,
- Not having mental or communication problems,
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 |
|---|---|---|
| self-efficacy supportself-efficacy support | Behavioural | Experimental |
Primary outcome
Self-Efficacy - Efficacy Scale
Time frame: 3months
The scale evaluates generic self-efficacy-efficacy perception and does not belong to any subjective category. The Self-Efficacy-Efficacy Scale is a 23-item, 5-point Likert-type scale with a minimum of 23 points and a maximum of 115 points.
Medication Adherence Self-Efficacy Scale in Hypertensive Patients
Time frame: 3months
The scale consists of 13 items and is in a four-point Likert type. The scale can be used to determine the lowest 13 and highest 52 points. The increase in the scale score shows that the individuals' compliance with the antihypertensive medication is above average.
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 7 Apr 2022.
- Derived from this study: PubMed 40133854Erden Y, Yildiz GN, Ciftci B, Avsar G, Ozek S, Ozbek E, Sarialioglu A. The effect of self-management program with tele-nursing based on the Roper-Logan-Tierney model on self-care of hypertensive patients: a randomized controlled trial. BMC Nurs. 2025 Mar 25;24(1):313. doi: 10.1186/s12912-025-02854-y.
- Individual participant dataSharing planned: No. The article is intented to be shared after it is published.
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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.
BAHAR Çiftçi, phd study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-efficacy support in people with Hypertension, run by Ataturk 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 8 inclusion and 8 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 7 Apr 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?
Self-Efficacy - Efficacy Scale (time frame: 3months). 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?
On the ClinicalTrials.gov record for NCT05316454, which also lists 1 linked publication.
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 7 Apr 2022; AzTrials last refreshed its copy on 2 Nov 2026.