UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058581 |
|---|---|
| Receipt number | R000066465 |
| Scientific Title | Association between medication adherence and trust and satisfaction with health care providers in patients with hypertension, diabetes, and dyslipidemia (THRIVE): a multi-center, prospective, observational study. |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/24 12:14:40 |
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Basic information
Public title
Association between medication adherence and trust and satisfaction with health care providers in patients with hypertension, diabetes, and dyslipidemia (THRIVE): a multi-center, prospective, observational study.
Acronym
THRIVE study
Scientific Title
Association between medication adherence and trust and satisfaction with health care providers in patients with hypertension, diabetes, and dyslipidemia (THRIVE): a multi-center, prospective, observational study.
Scientific Title:Acronym
THRIVE study
Region
| Japan |
Condition
Condition
hypertension, diabetes, dyslipidemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to assess and elucidate beliefs and concerns regarding medications-key components of medication adherence-among patients with chronic metabolic diseases (hypertension, diabetes, and dyslipidemia) who utilize community pharmacies.
Basic objectives2
Others
Basic objectives -Others
The study will examine associations between medication adherence and related factors, including trust in physicians and satisfaction with pharmacists.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The mean scores and 95% confidence intervals for the Adjusted Necessity Score (ANS), Adjusted Concern Scale (ACS), and the Necessity-Concern Differential (NCD) will be calculated and presented graphically for patients with hypertension, diabetes, and dyslipidemia.
Key secondary outcomes
The mean scores and 95% confidence intervals for the FACIT-Satisfaction with Pharmacist (FACITSWiP) and the short version of the Wake Forest Physician Trust Scale (WFPTS) will be calculated and presented graphically for patients with chronic metabolic diseases (hypertension, diabetes, and dyslipidemia).
To evaluate the relationship between satisfaction with pharmacists and trust in physicians, a scatter plot will be created using the FACIT-SWiP and WFPTS scores. The correlation coefficient and its 95% confidence interval will also be calculated.
The proportions of patients who experienced dose increases or additions of prescribed medications will be calculated at 6 months and 12 months, treating these as events.
Time to dose increase or addition of prescribed medications will be analyzed using the Kaplan-Meier method. Group comparisons based on baseline variables will be conducted using the log-rank test. Additionally, hazard ratios (HRs) and 95% confidence intervals (CIs) will be estimated using the Cox proportional hazards model to evaluate differences between groups.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Individuals aged 18 years or older
2. Patients who visit a community pharmacy and receive a prescription for themselves
3. Patients currently receiving pharmacological treatment (at least one active agent) for hypertension, diabetes, or dyslipidemia (any one or more of these conditions), and whose treatment includes a dose increase or the addition of a new medication
4. Patients who have provided written informed consent
Key exclusion criteria
1. Individuals with cognitive impairments that make it difficult to complete patient-reported outcome (PRO) questionnaires
2. Individuals with mental health conditions that make it difficult to complete PRO questionnaires
3. Individuals whose native language is not Japanese
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kawaguchi |
Organization
Tokyo University of Pharmacy and Life Sciences
Division name
Department of Clinical Assessment
Zip code
1920392
Address
1432-1, Horinouchi, Hachioji-city, Tokyo, Japan
TEL
042-676-5357
tkawa@toyaku.ac.jp
Public contact
Name of contact person
| 1st name | Ryohei |
| Middle name | |
| Last name | Soeishi |
Organization
Tokyo University of Pharmacy and Life Sciences
Division name
Department of Clinical Assessment
Zip code
1920392
Address
1432-1, Horinouchi, Hachioji-city, Tokyo, Japan
TEL
042-676-5111
Homepage URL
ryohei-soeishi@pharma802.com
Sponsor or person
Institute
Tokyo University of Pharmacy and Life Sciences
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo University of Pharmacy and Life Sciences
Address
1432-1, Horinouchi, Hachioji-city, Tokyo, Japan
Tel
042-676-5349
IRB@tokyo-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
八王子薬剤センター薬局
東京薬科大学附属薬局
八王子薬剤センター駅前薬局
西八王子調剤薬局
あらい薬局北野店
たちばな調剤薬局
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This multicenter, prospective observational study targets patients with chronic metabolic diseases-specifically hypertension, diabetes, and dyslipidemia-who visit community pharmacies in Japan. The study evaluates medication adherence using the Beliefs about Medicines Questionnaire (BMQ), trust in physicians via the short version of the Wake Forest Physician Trust Scale, and satisfaction with pharmacists via the FACIT-SWiP. Patients will complete these surveys at baseline, and follow-up data such as medication additions or dosage increases will be collected over a 12-month observation period. By analyzing these relationships, the study aims to clarify factors affecting adherence and to provide evidence for pharmacist intervention and policy development in real-world pharmacy practice in Japan.
Management information
Registered date
| 2025 | Year | 07 | Month | 24 | Day |
Last modified on
| 2025 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066465
