Trans-theoretical Model Based Home Visiting on Medication Behavior

NCT05951062 | Completed

• 1 other identifier: 2019-KY-143
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Medication Adherence

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  Sphygmomanometers，assessing Change from Baseline Blood Pressure at 3 years

  0.3month.6month.3years

Secondary Outcomes (3)

• medication adherence

  0.3month.6month.3years

• medication self-efficiency

  0.3month.6month.3years

• patient activation

  0.3month.6month.3years

Study Arms (2)

five sessions of educational interview

EXPERIMENTAL

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

treatment as usual

OTHER

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

Other: placebo group

Interventions

behavior management for anti-hypertensive medication BEHAVIORAL

five sessions of educational interview and home visiting to improve medication-related self-management skills

five sessions of educational interview

placebo group OTHER

treatment as usual

treatment as usual

Eligibility Criteria

• Age: 65 Years - 95 Years
• Gender Eligibility Details: \>=65y
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• aged 65 years of age or older
• 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
• prescribed anti-hypertensive medication by the physician for at least six months

You may not qualify if:

• unable to communicate and take medications by themselves.
• with an estimated life expectancy of no more than six months. -

Sponsors & Collaborators

• Jing Chang: lead

Study Sites (1)

Senior Residences of Henan Province

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Hypertension; Medication Adherence

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jing Chang, Master

  The First Affiliated Hospital of Zhengzhou University，Zhengzhou,China. ZIP：450000

  STUDY DIRECTOR

• YiJing Chen, Master

  Wuhan mental health center,Wuhan,China. ZIP：430000

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Cadre Health Office

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 18, 2023
• Study Start: November 1, 2018
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)