Clinical trial NCT05291000: The Role of Training and Reminder Wristwatche in Hypertension
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Adherence, Medication
Keywords: Elderly
Hypertension
Treatment Adherence
Training
Medication Reminder
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Maximum age (years): 92
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled experimental design
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

-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.

Exclusion Criteria:

* Being diagnosed with malignancy
* İlliteracy
* Having a history of cardiac intervention in the past year
* Hearing-vision loss

Primary outcomes:
measure: Antihypertensive Medication Treatment Adherence Scale (AMTAS)
timeFrame: 3 Month
measure: Medication Adherence Self-Efficacy Scale Short Form (MASES-SF)
timeFrame: 3 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Erbaa Family Health Center
state: Erbaa
Study officials:
affiliation: Ondokuz Mayıs University
name: Birsen ALTAY, Doç. Dr.
role: STUDY_DIRECTOR
References: