Middle-aged and Older Adults with Hypertension in Rural Communities

NCT06666361 | Recruiting

• 2 other identifiers: CMMC11309-L01IRB Serial No.: 11309-L01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Keywords

Hypertension; rural; health literacy; health promotion; middle-aged and older adults

Outcome Measures

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.

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

Secondary 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.

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

Study Arms (2)

Experimental Group:receiving intervention

EXPERIMENTAL

The experimental group participates in the Mobio Health Multimedia Hypertension Education Program, which includes a hypertension health education manual and a mobile health (m-health) intervention, aimed at enhancing participants' health literacy and promoting health-enhancing behaviors.

Other: Experimental Group

Control group :Non intervention

EXPERIMENTAL

In the control group, participants received the same hypertension health education manual as the experimental group.

Other: control group

Interventions

Experimental Group OTHER

The 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.

Experimental Group:receiving intervention

control group OTHER

The 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.

Control group :Non intervention

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Agree to participate in the study.

You may not qualify if:

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

Sponsors & Collaborators

• Chimei Medical Center: lead

Study Sites (1)

Chi Mei Hospital, Liouying

Tainan, Taiwan, 73657, Taiwan

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Su.Chiu Hsiao

  Chi Mei Medical Center,Liouying Director Nursing Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Man-Ting Cheng

CONTACT

+886 961062509; hate6699@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chi Mei Medical Center,Liouying, Director Nursing Department

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 30, 2024
• Study Start: December 7, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 10, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)