UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056668 |
|---|---|
| Receipt number | R000064767 |
| Scientific Title | Effectiveness of an Interprofessional Nutrition and Dysphagia Management Model for Care-Dependent Older Adults in Day Care Services: A Non-Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/01/08 |
| Last modified on | 2025/01/08 18:48:38 |
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Basic information
Public title
Interprofessional Nutrition and Dysphagia Management for Care-Dependent Older Adults in Day Care Services: A Non-Randomized Controlled Trial
Acronym
Nutrition and Dysphagia Management in Day Care
Scientific Title
Effectiveness of an Interprofessional Nutrition and Dysphagia Management Model for Care-Dependent Older Adults in Day Care Services: A Non-Randomized Controlled Trial
Scientific Title:Acronym
Nutrition and Dysphagia Management Day Care Study
Region
| Japan |
Condition
Condition
Malnutrition and Dysphagia
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of a preventive support model combining dietary observation assessments by non-specialized staff and consultation support by specialized staff for older adults requiring support in day care services.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of weight loss of 5 percent or more after 6 months
Key secondary outcomes
Changes in BMI (after 6 months)
Changes in Minimal Eating Observation Form-II (MEOF-II) scores
Changes in diet form based on the International Dysphagia Standardisation Initiative (IDDSI)
Changes in Functional Oral Intake Scale (FOIS) scores
Changes in Barthel Index (BI) scores (as an indicator of ADL)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Dietary observation assessments and weight measurements conducted by non-specialized staff, combined with monthly consultation support by specialized staff (approximately 5 minutes per person) for 3 months.
Interventions/Control_2
Usual care services without regular dietary observation assessments or consultation support by specialized staff.
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
| 65 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Older adults aged 65 years or older who are using adult day services
Participants who use day services at least twice a week
Individuals receiving services under the Japanese Long-Term Care Insurance system
Participants who provided consent to participate in the study
Key exclusion criteria
Participants receiving enteral nutrition
Participants with severe obesity (BMI > 35 kg/m2)
Participants for whom baseline weight measurement could not be obtained
Participants for whom baseline dietary observation could not be conducted
Participants who died, were hospitalized, or transferred during the study period
Target sample size
590
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Furuya |
Organization
The Nippon Dental University, Tama Oral Rehabilitation Clinic
Division name
Department of Oral Rehabilitation
Zip code
184-0011
Address
4-44-19 Higashi-cho, Koganei-shi, Tokyo 184-0011, Japan
TEL
0423166211
furuya-h@tky.ndu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Furuya |
Organization
The Nippon Dental University, Tama Oral Rehabilitation Clinic
Division name
Department of Oral Rehabilitation
Zip code
184-0011
Address
4-44-19 Higashi-cho, Koganei-shi, Tokyo 184-0011, Japan
TEL
0423166211
Homepage URL
furuya-h@tky.ndu.ac.jp
Sponsor or person
Institute
The Nippon Dental University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Nippon Dental University
Address
1-9-20 Fujimi, Chiyoda-ku, Tokyo 102-8159, Japan
Tel
+81-3-3261-8311
miuran@tky.ndu.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
つきみの園（東京都）、あんず苑（東京都）、あかしあ（滋賀県）、など全31施設
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 08 | Day |
Related information
URL releasing protocol
http://www.tmghig.jp/research/info/archives/012474/
Publication of results
Partially published
Result
URL related to results and publications
http://www.tmghig.jp/research/info/archives/012474/
Number of participants that the trial has enrolled
590
Results
This study enrolled 590 participants. After 6 months, weight loss was 10.1% in the intervention group and 17.2% in the control group (p < 0.05). The risk of weight loss was significantly reduced in the intervention group (odds ratio: 0.51, 95% CI: 0.31-0.84). Improvements were also seen in BMI and FOIS scores.
Results date posted
| 2025 | Year | 01 | Month | 08 | Day |
Results Delayed
Results Delay Reason
The results of this study were initially intended to be disclosed shortly after the study's completion. However, the process of data analysis and manuscript preparation took longer than expected, leading to delays in registration. Additionally, internal adjustments and report preparation contributed to the delay. Steps are being taken to ensure timely disclosure in future studies.
Date of the first journal publication of results
Baseline Characteristics
A total of 590 participants were enrolled in the study: 317 in the intervention group and 273 in the control group. The mean age of participants was 78.5 years (SD: 6.3), and all were older adults aged 65 years or older. Women accounted for 68% of the participants. All participants were receiving services under the Japanese Long-Term Care Insurance system and used day services at least twice a week. The mean BMI was 21.5 kg/m2 (SD: 2.8), with a high proportion of participants at risk of malnutrition.
Participant flow
In this study, 1,250 individuals were assessed for eligibility and assigned to the intervention group (n = 755) or the control group (n = 495). At baseline, 295 participants in the intervention group were excluded (BMI > 35: 2, tube feeding: 7, unable to obtain weight measurement: 107, unable to conduct meal observation: 36), as well as 101 participants in the control group (BMI > 35: 4, tube feeding: 1, unable to obtain weight measurement: 79, unable to conduct meal observation: 17). During the study, 143 participants in the intervention group were lost to follow-up (death: 26, hospitalization: 33, admission to long-term care facilities: 30, relocation: 4, assessment not conducted: 50), and 121 participants in the control group (death: 5, hospitalization: 9, admission to long-term care facilities: 8, relocation: 2, assessment not conducted: 97). Ultimately, 317 participants in the intervention group (male: 101, female: 216) and 273 in the control group (male: 82, female: 191) were included in the final analysis.
Adverse events
During the study period, the following adverse events were reported in the intervention and control groups. In the intervention group, there were 26 deaths, 33 hospitalizations, 30 admissions to long-term care facilities, and 4 relocations. In the control group, there were 5 deaths, 9 hospitalizations, 8 admissions to long-term care facilities, and 2 relocations. None of these events were related to the intervention and were not identified as risk factors during the study.
Outcome measures
Primary outcome:
-Rate of weight loss of 5 percent or more after 6 months
Secondary outcomes:
- Changes in BMI
- Changes in Minimal Eating Observation Form-II (MEOF-II) scores
- Changes in dietary forms based on the International Dysphagia Standardisation Initiative (IDDSI)
- Changes in Functional Oral Intake Scale (FOIS) scores
- Changes in Barthel Index (BI) scores measuring activities of daily living (ADL)
Plan to share IPD
There is no plan to share individual participant data (IPD) from this study.
IPD sharing Plan description
There is no plan to share individual participant data (IPD) from this study.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 11 | Month | 30 | Day |
Other
Other related information
The analysis of the trial results was delayed due to the time required for thorough data validation and additional statistical analyses. Internal adjustments within the research team and extended report preparation processes also contributed to the delay. Future efforts will focus on improving data management and analysis efficiency.
Management information
Registered date
| 2025 | Year | 01 | Month | 08 | Day |
Last modified on
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064767
