Trans-theoretical Model Based Home Visiting on Medication Behavior

NCT ID: NCT05951062

Last Updated: 2023-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2022-10-01

Brief Summary

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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

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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.

Conditions

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Hypertension Medication Adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

behavior management for anti-hypertensive medication

Intervention Type BEHAVIORAL

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

treatment as usual

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

Group Type OTHER

placebo group

Intervention Type OTHER

treatment as usual

Interventions

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behavior management for anti-hypertensive medication

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

Intervention Type BEHAVIORAL

placebo group

treatment as usual

Intervention Type OTHER

Eligibility Criteria

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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. -
Minimum Eligible Age

65 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jing Chang

OTHER

Sponsor Role lead

Responsible Party

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Jing Chang

Director of Cadre Health Office

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jing Chang, Master

Role: STUDY_DIRECTOR

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

YiJing Chen, Master

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Senior Residences of Henan Province

Zhengzhou, Henan, China

Site Status

Countries

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China

Other Identifiers

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2019-KY-143

Identifier Type: -

Identifier Source: org_study_id

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