Trans-theoretical Model Based Home Visiting on Medication Behavior

Hypertension Clinical Trial

Official title:

Benefits of Patient-centered Medication Management Education on Blood Pressure and Health Outcomes for Hypertensive Elderly Patients in Residential Care Facility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05951062
• Other study ID #: 2019-KY-143
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: October 1, 2022

Study information

• Verified date: July 2023
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was a single-blinded, two-armed, randomized controlled trial comparing a medication self-management intervention to usual care for hypertensive elderly in the residential care facility. To explore the effect of stage-matched tailored education on disease management for hypertensive elderly. Patient were randomly assigned to either a 6-month trans-theoretical model-based medication management intervention group or a treatment-as-usual group. we would like to improve its adherence to the medicine prescribed by their own physician through five sessions of face-to-face interview which focused on anti-hypertensive medication-related information, the importance of medication refills, motivation, self-management and self-check skills.

Description:

This study was a single-blinded, two-armed, randomized controlled trial comparing a medication self-management intervention to usual care for hypertensive elderly in the residential care facility. From October 2018 to November 2018, convenience sampling was used to recruit 120 participants from one of the most extensive facilities in Zhengzhou, China. Individuals aged 65 years of age or older diagnosed had stage I or stage II hypertension (140-159/90-99 mm Hg or 160-180/100-110 mm Hg, respectively), as confirmed by the professional physician and prescribed anti-hypertensive medication by the physician for at least six months and with an estimated life expectancy of no less than six months were included.The intervention included five educational sessions focused on anti-hypertensive medication-related information, the importance of medication refills, motivation, self-management and self-check skills.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 95 Years

Eligibility

Inclusion Criteria:

1. aged 65 years of age or older

2. diagnosed with a stage I or stage II hypertension (140-159/90-99 mm Hg or 160-180/100-110 mm Hg, respectively), as confirmed by the professional physician

3. prescribed anti-hypertensive medication by the physician for at least six months Exclusion Criteria

1. unable to communicate and take medications by themselves.

2. with an estimated life expectancy of no more than six months. -

Related Conditions & MeSH terms

• Hypertension
• Medication Adherence

Intervention

Behavioral:
• behavior management for anti-hypertensive medication
five sessions of educational interview and home visiting to improve medication-related self-management skills

Other:
• placebo group
treatment as usual

Locations

Country	Name	City	State
China	Senior Residences of Henan Province	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Jing Chang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	Sphygmomanometers,assessing Change from Baseline Blood Pressure at 3 years	0.3month.6month.3years
Secondary	medication adherence	Adherence to Refills and Medications Scale,The raw scores are changed from original metric to a 10-40 metric, in which lower scores means higher level of adherence	0.3month.6month.3years
Secondary	medication self-efficiency	Self-efficiency for appropriate medication use scale (SEAMS),It has 13 items and patients are asked about their level of confidence about taking medication correctly under a varied circumstance. Each item is evaluated by three-point Likert respond scale (1=not confident, 2=somewhat confident, 3=very confident), higher score means higher confidence	0.3month.6month.3years
Secondary	patient activation	patient activation measure-10 (PAM-10) scale.The raw scores are changed from original metric to a 0-100 metric, in which higher scores means higher level of activation	0.3month.6month.3years