Clinical trial NCT06666361: Middle-aged and Older Adults with Hypertension in Rural Communities
Official title: Health Literacy and Health Promotion Behaviors Among Middle-aged and Older Adults with Hypertension in Rural Communities: a Mixed Methods Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
rural
health literacy
health promotion
middle-aged and older adults
Lead sponsor: Chimei Medical Center
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 160
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 1.Total duration for Each Participant: 2 months Intervention Period: From December 2024 to December 2025
Secondary outcomes:
measure: 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.
timeFrame: 1.Total duration for Each Participant: 2 months Intervention. 2.Period: From December 2024 to December 2025
Other outcomes:
Locations:
city: Tainan City
country: Taiwan
facility: Chi Mei Hospital, Liouying
Study officials:
affiliation: Chi Mei Medical Center,Liouying Director Nursing Department
name: Su.Chiu Hsiao
role: PRINCIPAL_INVESTIGATOR
References: