Middle-aged and Older Adults with Hypertension in Rural Communities

Not Applicable

Recruiting

• Conditions: Hypertension

• Registration Number: NCT06666361
• Lead Sponsor: Chimei Medical Center

Brief Summary

Does the m-Health intervention have a positive effect on the health literacy and health promotion behaviors of the study participants?

Detailed Description

This study adopted a mixed methods study, and the first stage was a qualitative research design. The second phase was a quantitative research design aims to evaluate the effectiveness of applying healthy lifestyle intervention on the health literacy and health promotion behaviors among middle-aged and older adults with hypertension in rural communities. Recruitment is planned to be conducted in the cardiology outpatient clinic of a regional teaching hospital in the south. It will be a random assignment, single-blind, experimental research design, using simple random sampling to assign to the experimental group and the control group (experimental group: hypertension health education manual + m-Health; control group: hypertension health education manual), a two- month intervention program was carried out, and the questionnaire survey was conducted three times: once as a pre-test and twice as post-tests (during the 4th week and the 8th week of the intervention). Data analysis was conducted using statistical software (SPSS, version 22.0) for data management and statistical analysis, and analysis was conducted using descriptive statistics, independent sample t-test, chi-square test, and generalized estimating equations (GEE).

Study Timeline

• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-29
• Study First Posted: 2024-10-30
• Status Verified: 2024-12
• Study Start: 2024-12-07
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Diagnosed with hypertension for one year or more (including) and controlled with medication (systolic blood pressure ≥ 130 mmHg and diastolic blood pressure ≥ 80 mmHg).
2. Aware hypertensive patients aged ≥ 45 years with the ability to read and write.
3. Able to take medication independently.
4. Own a smartphone and are able to use it, and are willing to receive text messages (TxtM) or mobile health interventions (m-Health).
5. Agree to participate in the study.

Exclusion Criteria

1. Have cognitive impairments or mental disorders.
2. CCI (Charlson Comorbidity Index) score ≥ 3.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	1.Total duration for Each Participant: 2 months Intervention Period: From December 2024 to December 2025	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.

Secondary Outcome Measures

Name	Time	Method
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.	1.Total duration for Each Participant: 2 months Intervention. 2.Period: From December 2024 to December 2025	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).

Trial Locations

Locations (1)

Chi Mei Hospital, Liouying; 🇨🇳 Tainan City, Taiwan