Clinical trial NCT05951062: Trans-theoretical Model Based Home Visiting on Medication Behavior
Official title: Benefits of Patient-centered Medication Management Education on Blood Pressure and Health Outcomes for Hypertensive Elderly Patients in Residential Care Facility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Medication Adherence
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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. -

Primary outcomes:
measure: Blood Pressure
timeFrame: 0.3month.6month.3years
Secondary outcomes:
measure: medication adherence
timeFrame: 0.3month.6month.3years
measure: medication self-efficiency
timeFrame: 0.3month.6month.3years
measure: patient activation
timeFrame: 0.3month.6month.3years
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Senior Residences of Henan Province
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University，Zhengzhou,China. ZIP：450000
name: Jing Chang, Master
role: STUDY_DIRECTOR
affiliation: Wuhan mental health center,Wuhan,China. ZIP：430000
name: YiJing Chen, Master
role: PRINCIPAL_INVESTIGATOR
References: