Trans-theoretical Model Based Home Visiting on Medication Behavior

Study Overview
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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.

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

Conditions
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Hypertension, Medication Adherence

Intervention / Treatment
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* Behavioral: behavior management for anti-hypertensive medication
* Other: placebo group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria unable to communicate and take medications by themselves. with an estimated life expectancy of no more than six months. -

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: five sessions of educational interview<br>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<br>* five sessions of educational interview and home visiting to improve medication-related self-management skills<br>|
| Other: treatment as usual<br>usual care provided by facility,such as regular blood pressure checking and meals | Other: placebo group<br>* treatment as usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Sphygmomanometers，assessing Change from Baseline Blood Pressure at 3 years | 0.3month.6month.3years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |