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Completed

NCT Number: NCT05951062

Trans-theoretical Model Based Home Visiting on Medication Behavior

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.

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Key information

Age range

65 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Senior Residences of Henan Province

Zhengzhou, Henan, 450000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

behavior management for anti-hypertensive medication

Behavioral

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

Placebo Group

Other

treatment as usual

Primary outcomes

  1. Blood Pressure

    Time frame: 0.3month.6month.3years

    Sphygmomanometers,assessing Change from Baseline Blood Pressure at 3 years

Secondary outcomes

  1. medication adherence

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Jing Chang

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jul 18, 2023
Registry last updated
Jul 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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