Middle-aged and Older Adults with Hypertension in Rural Communities
ConditionHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorChimei Medical Center
About this trial
Does the m-Health intervention have a positive effect on the health literacy and health promotion behaviors of the study participants?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with hypertension for one year or more (including) and controlled with medication (systolic blood pressure ≥ 130 mmHg and diastolic blood pressure ≥ 80 mmHg).
Aware hypertensive patients aged ≥ 45 years with the ability to read and write.
Able to take medication independently.
Own a smartphone and are able to use it, and are willing to receive text messages (TxtM) or mobile health interventions (m-Health).
Disqualifiers
Have cognitive impairments or mental disorders.
CCI (Charlson Comorbidity Index) score ≥ 3.
Trial design
Design model
Parallel
Treatments tested in this trial
Experimental Group
Other interventionThe experimental group participates in the Mobio Health Multimedia Hypertension Promotion Program, which includes a hypertension education manual and a mobile health (m-health) intervention aimed at enhancing participants' health literacy and promoting healthy behaviors. In the first week, participants receive the health-education manual on-site, with face-to-face explanations and guidance on using mobile resources, such as text messaging, provided by the Sub-Investigator. The mobile health intervention transforms the manual's content into six video units, each covering a specific topic, and these videos are continuously pushed over a two-month period. Distributed through LINE@, the official LINE account of the nursing platform, participants can easily access information via the chat menu at the bottom of the screen. This setup improves accessibility, making it convenient for participants to locate and use essential health information directly from the chat window.
control group
Other interventionThe control group received one copy of the same health education manual as the experimental group. The sub-Investigator only explained how to use the manual, and afterwards, no face-to-face teaching or m-Health interventions were conducted. After the experiment concluded, the m-Health program used by the experimental group would be provided to the control group.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Experimental Group:receiving interventionExperimental treatment 1 intervention
Group B: Control group :Non interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
1.To explore the effectiveness of mobile health(m-health) interventions on the health literacy of study participants. 2.To explore the effectiveness of mobile health(m-health) interventions on the health promotion behaviors of study participants.
A structured questionnaire survery was administered at the start, and at the 4th and 8th weeks of the intervention to evaluate its effectiveness. The questionnaire includes:(1) The Hypertension Health Literacy Scale, with scores ranging from 10 to 40, where higher scores indicate better outcomes; (2) The short-form Chinese Health-Promoting Lifestyle Profile, with scores ranging from 24 to 96, where higher scores indicate better outcomes.
Time frame
1.Total duration for Each Participant: 2 months Intervention Period: From December 2024 to December 2025Secondary outcomes
1
1.To explore the factors influencing the health literacy of study participants. 2.To explore the factors influencing the health promotion behaviors of study participants.
A structured questionnaire was administered at the start, at weeks 4 and 8 of the intervention, and for post-intervention evaluation. The details are as follows: (1) Basic Characteristics, including age , gender, height (cm), weight (kg), BMI(weight and height will be combined to report BMI in in kg/m²), education, marital status, residential area, employment, economic status, living situation, clinic transportation, duration of hypertension, regular medication, and presence of other chronic diseases; (2) Hypertension Knowledge Scale( 0 to 10, higher scores = greater knowledge); (3) Adherence to Refills and Medications Scale (12-48, higher scores = better outcomes); (4) System Usability Scale, graded as: A (90-100), B (80-89), C (70-79), D (60-69), and F (0-59), with strong face validity and an average score of about 70; scores above 70 are considered acceptable; (5) Learning Satisfaction Questionnaire (12-60, higher scores= better outcomes).
Time frame
1.Total duration for Each Participant: 2 months Intervention. 2.Period: From December 2024 to December 2025Sponsors and contacts
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Source ClinicalTrials.gov