HypertensionNCT05951062
Trans-theoretical Model Based Home Visiting on Medication Behavior
A study testing behavior management for anti-hypertensive medication in people with Hypertension and Medication Adherence, run by Jing Chang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Hypertension, Medication Adherence
- What is being tested?
- behavior management for anti-hypertensive medication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- unable to communicate and take medications by themselves.
- with an estimated life expectancy of no more than six months. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits of Patient-centered Medication Management Education on Blood Pressure and Health Outcomes for Hypertensive Elderly Patients in Residential Care Facility
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.
Read the 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.
- Conditions
- Hypertension, Medication Adherence
- Being tested
- behavior management for anti-hypertensive medication, placebo group
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavior management for anti-hypertensive medicationBehavioural
five sessions of educational interview and home visiting to improve medication-related self-management skills
placebo groupOther
treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: behavior management for anti-hypertensive medication |
| treatment as usual | Other | usual care provided by facility,such as regular blood pressure checking and meals Receives: Other: placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Sphygmomanometers，assessing Change from Baseline Blood Pressure at 3 years
Measured: 0.3month.6month.3years
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 0.3month.6month.3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Nov 2018
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jing Chang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jing Chang, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Jing Chang, Master, Study director, The First Affiliated Hospital of Zhengzhou University，Zhengzhou,China. ZIP：450000YiJing Chen, Master, Principal investigator, Wuhan mental health center,Wuhan,China. ZIP：430000
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951062
- Sponsor's protocol ID
- 2019-KY-143
- Status last verified
- Jul 2023
- First submitted
- 20 Jun 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make data available.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Patient-centered Medication Management Education on Blood Pressure and Health Outcomes for Hypertensive Elderly Patients in Residential Care Facility
- ClinicalTrials.gov ID
- NCT05951062
- Acronym / sponsor ID
- 2019-KY-143
- Conditions
- Hypertension, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Jing ChangUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| five sessions of educational interview | Experimental | Behavioral: behavior management for anti-hypertensive medicationThe intervention included five educational sessions focused on anti-hypertensive medication-related information, the importance of medication refills, motivation, self-management and self-check skills. |
| treatment as usual | Other | Other: placebo groupusual care provided by facility,such as regular blood pressure checking and meals |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- unable to communicate and take medications by themselves.
- with an estimated life expectancy of no more than six months. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavior management for anti-hypertensive medicationfive sessions of educational interview and home visiting to improve medication-related self-management skills | Behavioural | five sessions of educational interview |
| placebo grouptreatment as usual | Other | treatment as usual |
Primary outcome
Blood Pressure
Time frame: 0.3month.6month.3years
Sphygmomanometers，assessing Change from Baseline Blood Pressure at 3 years
3 secondary outcomes
medication adherence
Time frame: 0.3month.6month.3years
medication self-efficiency
Time frame: 0.3month.6month.3years
patient activation
Time frame: 0.3month.6month.3years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: No. There is not a plan to make data available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Chang, Master study director
The First Affiliated Hospital of Zhengzhou University，Zhengzhou,China. ZIP：450000
YiJing Chen, Master principal investigator
Wuhan mental health center,Wuhan,China. ZIP：430000
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavior management for anti-hypertensive medication in people with Hypertension and Medication Adherence, run by Jing Chang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: 0.3month.6month.3years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.