HypertensionRoT-ReWiHNCT05291000
The Role of Training and Reminder Wristwatche in Hypertension
A study testing The Role of Training and Reminder Wristwatche in Hypertension (RoT-ReWiH) in people with Hypertension and Adherence, Medication, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study is a randomized controlled study. The study was completed to with randomized selected 30 training and reminder by watch (experiment), 30 education (experiment) and 30 control group total of 90 hypertensive patients. Read more about this study
- Who is it for?
- Ages 65 to 92 years
- Conditions the study is for
- Hypertension, Adherence, Medication
- What is being tested?
- The Role of Training and Reminder Wristwatche in Hypertension (RoT-ReWiH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 31 Dec 2020
- 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 65 to 92 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- -The patients who were 65 and older, who were diagnosed with hypertension, who used at least one antihypertensive drug, who are literate and open to communication and cooperation, who had blood pressure of 140/90mmHg or above prior to the research, who had a score of 8 and above from the Compliance with Drug Therapy Scale, and who were willing to participate were included in the study.
Who cannot join
- Being diagnosed with malignancy
- İlliteracy
- Having a history of cardiac intervention in the past year
- Hearing-vision loss
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erbaa Family Health Center
Tokat Province, Erbaa
About this study
Official title: The Role of Training And Medication Reminder Wristwatch in the Adherence to The Treatment in Geriatric Patients Diagnosed With Hypertension: A Randomized Controlled Trial (RoT-ReWiH)
This study is a randomized controlled study. The study was completed to with randomized selected 30 training and reminder by watch (experiment), 30 education (experiment) and 30 control group total of 90 hypertensive patients. Patients in the experimental group received training on hypertension and treatment adherence. In addition, the participants in the training and reminder by watch group wore a medication reminder wristwatch. Statistically significant differences were found in the post-test between scale scores of the experimental and control groups (p<.05). It was observed that the initial blood pressure measurements were high in the patients in all three groups, while the highest decrease was found in the training and reminder by wristwatch group at the final measurement (p<.05). Hypertension education program and using a medication reminder wristwatch were found to be effective in increasing treatment adherence.
Read the detailed description
Design and Participants This study was conducted a randomized controlled trial. The population of the research was the patients who received service from this center, who were 65 years of age and older, who had hypertension, and who were using at least one antihypertensive drug (n=90). Power analysis was conducted to determine the sample size; it was based on the difference in Compliance with Drug Therapy Scale mean scores of hypertensive patients from previous studies.16 The sample size of at least 60 individuals was calculated by taking α = 0.05, power = 0.99, and effect size = 0.863. Keeping in mind that the number of participants may decrease during the study owing to factors such as a health problems or die , 90 subjects were included in the study.
Participants were randomized to medication reminder wristwatch group (n = 30), training group (n = 30) and control (n = 30) groups. In randomization, participants were stratified participants was ensured through the use of stratified sampling method. The patients in all three groups were stratified according to gender (female, male). The patients who were 65 and older, who were diagnosed with hypertension, who used at least one antihypertensive drug, who are literate and open to communication and cooperation, who had blood pressure of 140/90mmHg or above prior to the research, who had a score of 8 and above from the Compliance with Drug Therapy Scale, and who were willing to participate were included in the study. The patients who met the inclusion criteria constituted the sample of the study.
A questionnaire form, Hypertension Information Form (HIF), Antihypertensive Medication Treatment Adherence Scale (AMTAS), Medication Adherence Self-Efficacy Scale Short Form (MASES-SF) were used to collect data. The questionnaire form was developed by using relevant literature and included 33 closed-ended questions about the sociodemographic, health/disease and treatment compliance characteristics of elderly individuals.
Hypertension Information Form (HIF) was prepared by the researcher in line with the literature in order to measure the effectiveness of the hypertension education program. It contains 26 statements about drug use, blood pressure monitoring, and disease management. The questions are Yes/No questions. The "yes" answers receive 1 point, while the "no" answers receive 0 point. The maximum score that can be obtained from the form is 26. A score of 13 and above indicates that patients' knowledge level about hypertension has increased. The current study found Cronbach α = 0.77.
AMTAS is a questionnaire developed by Morisky et al to evaluate medication adherence of individuals with hypertensive in 2003. The scale includes 9 statements to diagnose the medication behavior and the total score varies between 1 and 13. Individuals with a score between 1 and 7 are defined as compliant with treatment, while individuals with a score of 8 and above are defined as non-compliant with treatment. The Turkish version of the AMTAS was validated by Demirezen et al with Cronbach α = 0.82. In this study, the Cronbach's alpha of the scale was determined as 0.51.
MASES-SF was developed in 2012 by Hacıhasanoğlu et al and include of 13 questions on a Likert scale. The total score of the scale is between 13 and 52, and an increase in the score indicates that the individual's level of compliance with antihypertensive drug treatment is good. The Cronbach's alpha was reported as 0.94. In this study, the Cronbach's alpha of the scale was found to be 0.83.
The study was conducted between April 2019 and November 2020. In the first meeting, The questionnaire form, HIF, AMTAS, MASES-SF were administered. Data were collected using the face-to-face interview method.
Ethical approval was obtained from the ethical board (February 18, 2018, No. 83116987-662) and permission was given from the Provincial Health Directorate (February 28, 2019, No. 87064461-044). Participants were informed about the scope of the study and verbal and written informed consent was obtained. Educational material was given to participants of the control group after the last home visit.
The data were analyzed using the SPSS 23.0. Chi-square and Fisher's Exact Tests were used to compare the categorical variables across the groups. One-way Analysis of Variance was used to compare the data that show normal distribution according to groups of three or more, and the Kruskal Wallis Test was used to compare data that were not normally distributed. The paired two-sample t-test was used to compare normally distributed data according to paired time, and the Wilcoxon Test was used to compare the data that did not show normal distribution. The McNemar Test was used to compare the categorical variables according to pretest and posttest. For statistical significance, P < .05 was used.
- Conditions
- Hypertension, Adherence, Medication
- Being tested
- The Role of Training and Reminder Wristwatche in Hypertension (RoT-ReWiH)
- Keywords
- Elderly, Hypertension, Treatment Adherence, Training, Medication Reminder
- Medical subject headings
- Hypertension, Medication Adherence, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Role of Training and Reminder Wristwatche in Hypertension (RoT-ReWiH)Behavioural
The present study revealed that multiple interventions such as home visits to elderly hypertensive patients, training program, telephone counseling, and the use of medication reminder wristwatch are effective in increasing treatment adherence and self-efficacy, and in controlling blood pressure. In this direction, health professionals working in primary care are recommended that they make regular home visits, encourage patients to take responsibility for health, and organize regular and interdisciplinary training and counseling programs in the management of hypertension.
| Study group | Role | What they receive |
|---|---|---|
| RoT-ReWiH | Experimental | First, pre-tests were applied to the patients in the training and reminder by watch group at first home visit.Second home visits were conducted participants 12th weeks after the first home visit.One of the researchers presented the education program to individuals with hypertensive.The education program included issues related to hypertension, measurament of pressure blood, lifestyle changes and adherence to treatment. The program using face-to-face communication technique and lasted about 45 minutes.For the patients in this group, the alarm time was set according to the time when blood pressure medication was taken, the cord was adjusted according to the arm, and then information was given about the use of the watch. At the end of the interview, the blood pressure of the experimental groups was measured and the measurement value was recorded on the blood pressure follow-up card. Receives: Behavioral: The Role of Training and Reminder Wristwatche in Hypertension (RoT-ReWiH) |
| Training group | Experimental | First, pre-tests were applied to the patients in the training group at first home visit.The education program included issues related to hypertension, measurament of pressure blood, lifestyle changes and adherence to treatment. The program using face-to-face communication technique and lasted about 45 minutes. In addition, other drugs used by individuals at home (such as painkillers, antibiotics) were also evaluated during the home visit, and a red label was made on the antihypertensive drug box to distinguish antihypertensive drugs from other drugs. At the end of the interview, the blood pressure of the experimental groups was measured and the measurement value was recorded on the blood pressure follow-up card. Receives: Behavioral: The Role of Training and Reminder Wristwatche in Hypertension (RoT-ReWiH) |
| Control group | No intervention | Pre-tests was applied to the patients in the control group.No intervention was be applied to the patients in this group and second home visit 12th weeks after the first home visit and were readministered the post-tests. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antihypertensive Medication Treatment Adherence Scale (AMTAS)
AMTAS is a questionnaire developed by Morisky et al to evaluate medication adherence of individuals with hypertensive in 2003. The scale includes 9 statements to diagnose the medication behavior and the total score varies between 1 and 13. Individuals with a score between 1 and 7 are defined as compliant with treatment, while individuals with a score of 8 and above are defined as non-compliant with treatment. The Turkish version of the AMTAS was validated by Demirezen et al. with Cronbach α = 0.82. In this study, the Cronbach's alpha of the scale was determined as 0.51.
Measured: 3 Month
Medication Adherence Self-Efficacy Scale Short Form (MASES-SF)
MASES-SF was developed in 2012 by Hacıhasanoğlu et al and include of 13 questions on a Likert scale. The total score of the scale is between 13 and 52, and an increase in the score indicates that the individual's level of compliance with antihypertensive drug treatment is good. The Cronbach's alpha was reported as 0.94. In this study, the Cronbach's alpha of the scale was found to be 0.83.
Measured: 3 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 Apr 2019
- Primary completion30 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled experimental design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birsen ALTAY, Ondokuz Mayıs University
- Investigators
- Birsen ALTAY, Doç. Dr., Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291000
- Sponsor's protocol ID
- 83116987-662
- Acronym
- RoT-ReWiH
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Training And Medication Reminder Wristwatch in the Adherence to The Treatment in Geriatric Patients Diagnosed With Hypertension: A Randomized Controlled Trial (RoT-ReWiH)
- ClinicalTrials.gov ID
- NCT05291000
- Acronym / sponsor ID
- RoT-ReWiH / 83116987-662
- Conditions
- Hypertension, Adherence, Medication
- Keywords
- Elderly, Hypertension, Treatment Adherence, Training, Medication Reminder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 22 Mar 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.
This study is a randomized controlled study. The study was completed to with randomized selected 30 training and reminder by watch (experiment), 30 education (experiment) and 30 control group total of 90 hypertensive patients. Patients in the experimental group received training on hypertension and treatment adherence. In addition, the participants in the training and reminder by watch group wore a medication reminder wristwatch. Statistically significant differences were found in the post-test between scale scores of the experimental and control groups (p<.05). It was observed that the initial blood pressure measurements were high in the patients in all three groups, while the highest decrease was found in the training and reminder by wristwatch group at the final measurement (p<.05). Hypertension education program and using a medication reminder wristwatch were found to be effective in increasing treatment adherence.
Detailed description
Design and Participants This study was conducted a randomized controlled trial. The population of the research was the patients who received service from this center, who were 65 years of age and older, who had hypertension, and who were using at least one antihypertensive drug (n=90). Power analysis was conducted to determine the sample size; it was based on the difference in Compliance with Drug Therapy Scale mean scores of hypertensive patients from previous studies.16 The sample size of at least 60 individuals was calculated by taking α = 0.05, power = 0.99, and effect size = 0.863. Keeping in mind that the number of participants may decrease during the study owing to factors such as a health problems or die , 90 subjects were included in the study.
Participants were randomized to medication reminder wristwatch group (n = 30), training group (n = 30) and control (n = 30) groups. In randomization, participants were stratified participants was ensured through the use of stratified sampling method. The patients in all three groups were stratified according to gender (female, male). The patients who were 65 and older, who were diagnosed with hypertension, who used at least one antihypertensive drug, who are literate and open to communication and cooperation, who had blood pressure of 140/90mmHg or above prior to the research, who had a score of 8 and above from the Compliance with Drug Therapy Scale, and who were willing to participate were included in the study. The patients who met the inclusion criteria constituted the sample of the study.
A questionnaire form, Hypertension Information Form (HIF), Antihypertensive Medication Treatment Adherence Scale (AMTAS), Medication Adherence Self-Efficacy Scale Short Form (MASES-SF) were used to collect data. The questionnaire form was developed by using relevant literature and included 33 closed-ended questions about the sociodemographic, health/disease and treatment compliance characteristics of elderly individuals.
Hypertension Information Form (HIF) was prepared by the researcher in line with the literature in order to measure the effectiveness of the hypertension education program. It contains 26 statements about drug use, blood pressure monitoring, and disease management. The questions are Yes/No questions. The "yes" answers receive 1 point, while the "no" answers receive 0 point. The maximum score that can be obtained from the form is 26. A score of 13 and above indicates that patients' knowledge level about hypertension has increased. The current study found Cronbach α = 0.77.
AMTAS is a questionnaire developed by Morisky et al to evaluate medication adherence of individuals with hypertensive in 2003. The scale includes 9 statements to diagnose the medication behavior and the total score varies between 1 and 13. Individuals with a score between 1 and 7 are defined as compliant with treatment, while individuals with a score of 8 and above are defined as non-compliant with treatment. The Turkish version of the AMTAS was validated by Demirezen et al with Cronbach α = 0.82. In this study, the Cronbach's alpha of the scale was determined as 0.51.
MASES-SF was developed in 2012 by Hacıhasanoğlu et al and include of 13 questions on a Likert scale. The total score of the scale is between 13 and 52, and an increase in the score indicates that the individual's level of compliance with antihypertensive drug treatment is good. The Cronbach's alpha was reported as 0.94. In this study, the Cronbach's alpha of the scale was found to be 0.83.
The study was conducted between April 2019 and November 2020. In the first meeting, The questionnaire form, HIF, AMTAS, MASES-SF were administered. Data were collected using the face-to-face interview method.
Ethical approval was obtained from the ethical board (February 18, 2018, No. 83116987-662) and permission was given from the Provincial Health Directorate (February 28, 2019, No. 87064461-044). Participants were informed about the scope of the study and verbal and written informed consent was obtained. Educational material was given to participants of the control group after the last home visit.
The data were analyzed using the SPSS 23.0. Chi-square and Fisher's Exact Tests were used to compare the categorical variables across the groups. One-way Analysis of Variance was used to compare the data that show normal distribution according to groups of three or more, and the Kruskal Wallis Test was used to compare data that were not normally distributed. The paired two-sample t-test was used to compare normally distributed data according to paired time, and the Wilcoxon Test was used to compare the data that did not show normal distribution. The McNemar Test was used to compare the categorical variables according to pretest and posttest. For statistical significance, P < .05 was used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized controlled experimental design
| Arm | Type | Receives |
|---|---|---|
| RoT-ReWiH | Experimental | Behavioral: The Role of Training and Reminder Wristwatche in Hypertension (RoT-ReWiH)First, pre-tests were applied to the patients in the training and reminder by watch group at first home visit.Second home visits were conducted participants 12th weeks after the first home visit.One of the researchers presented the education program to individuals with hypertensive.The education program included issues related to hypertension, measurament of pressure blood, lifestyle changes and adherence to treatment. The program using face-to-face communication technique and lasted about 45 minutes.For the patients in this group, the alarm time was set according to the time when blood pressure medication was taken, the cord was adjusted according to the arm, and then information was given about the use of the watch. At the end of the interview, the blood pressure of the experimental groups was measured and the measurement value was recorded on the blood pressure follow-up card. |
| Training group | Experimental | Behavioral: The Role of Training and Reminder Wristwatche in Hypertension (RoT-ReWiH)First, pre-tests were applied to the patients in the training group at first home visit.The education program included issues related to hypertension, measurament of pressure blood, lifestyle changes and adherence to treatment. The program using face-to-face communication technique and lasted about 45 minutes. In addition, other drugs used by individuals at home (such as painkillers, antibiotics) were also evaluated during the home visit, and a red label was made on the antihypertensive drug box to distinguish antihypertensive drugs from other drugs. At the end of the interview, the blood pressure of the experimental groups was measured and the measurement value was recorded on the blood pressure follow-up card. |
| Control group | No intervention | –Pre-tests was applied to the patients in the control group.No intervention was be applied to the patients in this group and second home visit 12th weeks after the first home visit and were readministered the post-tests. |
Who may qualify
- Ages
- 65 to 92 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- -The patients who were 65 and older, who were diagnosed with hypertension, who used at least one antihypertensive drug, who are literate and open to communication and cooperation, who had blood pressure of 140/90mmHg or above prior to the research, who had a score of 8 and above from the Compliance with Drug Therapy Scale, and who were willing to participate were included in the study.
Key exclusion criteria (4 listed)
- Being diagnosed with malignancy
- İlliteracy
- Having a history of cardiac intervention in the past year
- Hearing-vision loss
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 |
|---|---|---|
| The Role of Training and Reminder Wristwatche in Hypertension (RoT-ReWiH)The present study revealed that multiple interventions such as home visits to elderly hypertensive patients, training program, telephone counseling, and the use of medication reminder wristwatch are effective in increasing treatment adherence and self-efficacy, and in controlling blood pressure. In this direction, health professionals working in primary care are recommended that they make regular home visits, encourage patients to take responsibility for health, and organize regular and interdisciplinary training and counseling programs in the management of hypertension. | Behavioural | RoT-ReWiH, Training group |
Primary outcome
Antihypertensive Medication Treatment Adherence Scale (AMTAS)
Time frame: 3 Month
AMTAS is a questionnaire developed by Morisky et al to evaluate medication adherence of individuals with hypertensive in 2003. The scale includes 9 statements to diagnose the medication behavior and the total score varies between 1 and 13. Individuals with a score between 1 and 7 are defined as compliant with treatment, while individuals with a score of 8 and above are defined as non-compliant with treatment. The Turkish version of the AMTAS was validated by Demirezen et al. with Cronbach α = 0.82. In this study, the Cronbach's alpha of the scale was determined as 0.51.
Medication Adherence Self-Efficacy Scale Short Form (MASES-SF)
Time frame: 3 Month
MASES-SF was developed in 2012 by Hacıhasanoğlu et al and include of 13 questions on a Likert scale. The total score of the scale is between 13 and 52, and an increase in the score indicates that the individual's level of compliance with antihypertensive drug treatment is good. The Cronbach's alpha was reported as 0.94. In this study, the Cronbach's alpha of the scale was found to be 0.83.
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 22 Mar 2022.
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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.
Birsen ALTAY, Doç. Dr. study director
Ondokuz Mayıs 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 The Role of Training and Reminder Wristwatche in Hypertension (RoT-ReWiH) in people with Hypertension and Adherence, Medication, run by Ondokuz Mayıs 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 1 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 22 Mar 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?
Antihypertensive Medication Treatment Adherence Scale (AMTAS) (time frame: 3 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 22 Mar 2022.