UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059019 |
|---|---|
| Receipt number | R000067495 |
| Scientific Title | Effects of a Pottery Program in Community Pharmacy on the Physical and Psychosocial Health of Older Adults |
| Date of disclosure of the study information | 2025/09/06 |
| Last modified on | 2025/09/06 12:29:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of a Pottery Program in Community Pharmacy on the Physical and Psychosocial Health of Older Adults
Acronym
P-ART Study
Scientific Title
Effects of a Pottery Program in Community Pharmacy on the Physical and Psychosocial Health of Older Adults
Scientific Title:Acronym
P-ART Study
Region
| Japan |
Condition
Condition
Not applicable (community-dwelling older adults aged 75 years or older with independent ADL)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of a community-pharmacy-based "Pottery + Health Monitoring Program (Senior Plan)" on social connectedness (LSNS-6 as the primary focus) and on physical, cognitive, sleep, and depressive symptoms through a 12-24-month longitudinal intervention.
Basic objectives2
Others
Basic objectives -Others
To assess reduction in social isolation risk (proportion with LSNS-6 <12) and to identify program improvement areas via satisfaction/CS analysis and continuity of participation.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change from baseline to 12 months in the median Lubben Social Network Scale-6 (LSNS-6) score. Timepoints: baseline, 3, 6, 12, 18, 24 months (primary assessment at 12 months)
Key secondary outcomes
Social and Subjective Outcomes
Comparison of the proportion with LSNS-6 <12 before and after (social isolation risk)
Timing: baseline, 3, 6, 12, 18, 24 months
Original questionnaire (items on effects of pottery: 1-5 points, total score and median; dichotomized analysis 1-3 vs 4-5)
Timing: same as above
Satisfaction survey (cross-analysis of importance x satisfaction using CS analysis, qualitative analysis of free-text comments)
Timing: 12 and 24 months
Physical Function and Vital Signs
Body weight (each session / evaluation points)
BMI (evaluation points)
Blood pressure (each session / evaluation points)
Pulse rate (each session / evaluation points)
SpO2 (each session / evaluation points)
Grip strength (evaluation points; maximum value using Smedley dynamometer)
Reaction time (ruler drop test: mean value)
5 m walking test (usual and maximum walking time; mean of 2 trials)
Manual dexterity (Purdue Pegboard):
- Number of pegs inserted in 30 seconds (right and left hand)
- Number of assemblies completed in 1 minute
Timing: items 4-12 at baseline, 3, 6, 12, 18, 24 months
(body weight, blood pressure, pulse rate, SpO2, and grip strength also measured at each session)
Cognitive, Sleep, Mood, and Ikigai
Mini-Cog (total score)
Athens Insomnia Scale (AIS) (total score)
Geriatric Depression Scale GDS-15 (total score)
Ikigai Scale (total score)
Timing: baseline, 3, 6, 12, 18, 24 months
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Pottery + Health Monitoring Program (Senior Plan):
Once per week, 60-90 minutes per session, for 12-24 months. At each session, measure body weight, blood pressure, pulse rate, SpO2, and grip strength, with brief health guidance as needed.
Primary assessment at 12 months. Assessments at baseline, 3, 6, 12, 18, and 24 months.
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Community-dwelling older adults aged 75 years or older
Independent in ADL
Able to understand the study and provide written informed consent
Able to attend pottery sessions throughout the study period
LSNS-6 can be assessed at baseline
Key exclusion criteria
Medical conditions that preclude safe participation (e.g., severe or unstable cardiopulmonary disease)
Severe upper-limb functional impairment or severe visual/hearing impairment that prevents safe pottery work or outcome assessments
Cognitive impairment that precludes consent or adherence
Considered inappropriate by the investigator
Residents of institutional care facilities (not community-dwelling)
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | TOSHIKI |
| Middle name | |
| Last name | MURASAKA |
Organization
Konan pharmacy
Division name
Pharmacy
Zip code
5140315
Address
1874-4 Karasu, Tsu, Mie, Japan
TEL
0592927011
konanpharma@gmail.com
Public contact
Name of contact person
| 1st name | TOSHIKI |
| Middle name | |
| Last name | MURASAKA |
Organization
Konan Pharmacy
Division name
Research Office
Zip code
514-0315
Address
1874-4 Karasu-cho, Tsu-shi, Mie 514-0315, Japan
TEL
059-292-7011
Homepage URL
konanpharma@gmail.com
Sponsor or person
Institute
Konan Pharmacy
Institute
Department
Personal name
Funding Source
Organization
Konan Pharmacy
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
Research Ethics Review Committee of the Mie Pharmaceutical Association
Address
312-1 Shimazaki-cho, Tsu-shi, Mie, Japan
Tel
059-228-5995
my-di@mieyaku.or.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
こうなん薬局（三重県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 11 | Day |
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
| 2029 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 06 | Day |
Last modified on
| 2025 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067495
