Evaluating the Effectiveness of PHR and Online Medical Consultations in Community Health Management

JRCT ID: jRCT1042230097

Registered date:21/10/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: type 2 diabetes mellitus
• Date of first enrollment: 21/10/2023
• Target sample size: 100
• Study type: Observational

Outcome(s)

Primary Outcome

The amount of change in the percentage achievement of the composite endpoint* from the year of enrollment to the health examination in the year following enrollment
*A person who has achieved all of the following: diabetes, chronic kidney disease (CKD), and sarcopenia/locomotive syndrome. The diagnosis of each disease shall be in accordance with "5. Diagnostic Criteria".
(1) No diabetes mellitus or HbA1c within the target range for control
(2) No CKD, or CKD stage improved compared to that before the start of the intervention
No sarcopenia or locomotive syndrome

Secondary Outcome

Change in HbA1c from the year of registration to the next year's checkup
Change in body weight from the year of registration to the next annual checkup
Change in skeletal muscle mass from the year of registration to the next annual checkup
Change in SMI from the year of registration to the next annual checkup
Change in grip strength from the fiscal year of registration to the next fiscal year of checkups
Change in five chair stand test from the fiscal year of registration to the next fiscal year of checkups
Change in 2-step test from the year of registration to the next annual checkup
Timed Up and Go Test from the year of registration to the next annual medical checkup
Change in eGFR from the year of registration to the next annual checkup
Change in urine albumin/creatinine ratio from the year of registration to the next annual checkup
Change in urine protein titration from the year of registration to the next annual checkup
Change in locomo 25 from the year of registration to the next annual checkup
Change in the Brief Dietary History Questionnaire (BDHQ) from the fiscal year of registration to the next fiscal year of checkup
Change in Cognitive and Life Functioning Questionnaire (DASC-8) from the registration year to the next annual health checkup
Difference between the rate of decline in eGFR predicted from data for the 3 years prior to the registration year and the rate of decline from the registration year to the next year's medical checkup

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable

Include criteria

Persons who meet all of the following criteria are eligible.
1) Persons 65 years of age or older at the time of obtaining consent.
2) Persons residing in Sekigahara-cho who have received the specified health checkup and Sukoyaka health checkup and visited the hospital as a result of a medical checkup recommendation.
3) Persons who agree to the use of their data at Gifu University Hospital.
4) Persons who have given written consent to participate in the research.

Exclude criteria

Persons who fall into any of the following categories shall be excluded from this study
(1) Persons who have difficulty following the instructions of the principal investigator or subinvestigator
(2) Persons who are participating in other research, clinical research, etc.
(3) Other persons who are deemed inappropriate for this clinical research by the principal investigator or subinvestigator.

Related Information

• Primary Sponsor: Yabe Daisuke