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Trans-theoretical Model Based Home Visiting on Medication Behavior

Sponsor
Jing Chang (Other)
Overall Status
Completed
CT.gov ID
NCT05951062
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
47
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: behavior management for anti-hypertensive medication
  • Other: placebo group
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Benefits of Patient-centered Medication Management Education on Blood Pressure and Health Outcomes for Hypertensive Elderly Patients in Residential Care Facility
Actual Study Start Date :
Nov 1, 2018
Actual Primary Completion Date :
Oct 1, 2022
Actual Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: five sessions of educational interview

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.

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

usual care provided by facility,such as regular blood pressure checking and meals

Other: placebo group
treatment as usual

Outcome Measures

Primary Outcome Measures

  1. Blood Pressure [0.3month.6month.3years]

    Sphygmomanometers，assessing Change from Baseline Blood Pressure at 3 years

Secondary Outcome Measures

  1. medication adherence [0.3month.6month.3years]

    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

  2. medication self-efficiency [0.3month.6month.3years]

    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

  3. patient activation [0.3month.6month.3years]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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. -

Contacts and Locations

Locations

Site City State Country Postal Code
1 Senior Residences of Henan Province Zhengzhou Henan China 450000

Sponsors and Collaborators

  • Jing Chang

Investigators

  • Study Director: Jing Chang, Master, The First Affiliated Hospital of Zhengzhou University，Zhengzhou,China. ZIP：450000
  • Principal Investigator: YiJing Chen, Master, Wuhan mental health center,Wuhan,China. ZIP：430000

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jing Chang, Director of Cadre Health Office, The First Affiliated Hospital of Zhengzhou University
ClinicalTrials.gov Identifier:
NCT05951062
Other Study ID Numbers:
  • 2019-KY-143
First Posted:
Jul 18, 2023
Last Update Posted:
Jul 18, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hypertension
Antihypertensive Agents

Study Results

No Results Posted as of Jul 18, 2023