NCT05291000

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

1.7 years

First QC Date

March 14, 2022

Last Update Submit

March 14, 2022

Conditions

Keywords

ElderlyHypertensionTreatment AdherenceTrainingMedication Reminder

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    3 Month

Study Arms (3)

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.

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.

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.

Interventions

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.

RoT-ReWiHTraining group

Eligibility Criteria

Age65 Years - 92 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erbaa Family Health Center

Tokat Province, Erbaa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HypertensionMedication AdherenceTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient CompliancePatient Acceptance of Health CareHealth BehaviorBehavior

Study Officials

  • Birsen ALTAY, Doç. Dr.

    Ondokuz Mayıs University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled experimental design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Nursing Department

Study Record Dates

First Submitted

March 14, 2022

First Posted

March 22, 2022

Study Start

April 1, 2019

Primary Completion

November 30, 2020

Study Completion

December 31, 2020

Last Updated

March 22, 2022

Record last verified: 2022-03

Locations