UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027073 |
|---|---|
| Receipt number | R000031034 |
| Scientific Title | Project for enhancing the preventive measures for diabetes in Philippines: Effects of Diabetes Self-management and Peer Support Program based on Social Cognitive Theory |
| Date of disclosure of the study information | 2017/04/25 |
| Last modified on | 2021/10/28 15:23:40 |
* 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
Project for enhancing the preventive measures for diabetes in Philippines:
Effects of Diabetes Self-management and Peer Support Program based on Social Cognitive Theory
Acronym
Project for enhancing the preventive measures for diabetes in Philippines
Scientific Title
Project for enhancing the preventive measures for diabetes in Philippines:
Effects of Diabetes Self-management and Peer Support Program based on Social Cognitive Theory
Scientific Title:Acronym
Project for enhancing the preventive measures for diabetes in Philippines
Region
| Asia(except Japan) |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.To evaluate the diabetic patient's current characterization and risk factors for diabetes: identify the relationship between demographic characteristics, social support, medical and physical condition, knowledge, attitudes, self-efficacy, and self-management activities on diabetes-related indices.
2.To implement a peer support program based on social cognitive theory in order to cultivate peer leaders for patients with diabetes and evaluate its short- and long-term effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c, QOL
Key secondary outcomes
knowledge, attitudes, self-efficacy, and self-management activities
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
a peer support program based on social cognitive theory in order to cultivate peer leaders for patients with diabetes
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Over 20 years of age at time of consent
2.Diagnosed with diabetes and visiting a diabetes clinic
3.Ability to walk to where the survey was performed without other help
4.Ability to provide self-reported data
5.Ability to understand and sign an informed consent form
Key exclusion criteria
1.Comorbidities such as severe renal dysfunction, retinopathy, and gangrene requiring hospitalization, with difficulty in completing surveys or participating during measurements
2.Dementia, with difficulty in completing surveys or participating during measurements
3.Mental illness, with difficulty in completing surveys or participating during measurements
4.Pregnancy, or with incurable diseases of the musculoskeletal system, who have difficulty participating in measurements or cannot exercise
5.Others deemed inappropriate as participants for the study by the responsible physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Chika |
| Middle name | |
| Last name | Tanimura |
Organization
Tottori university
Division name
School of health sciences, Faculty of medicine
Zip code
683-8503
Address
86 Nishimachi, Yonago, Tottori
TEL
0859-38-6315
chika01@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Chika |
| Middle name | |
| Last name | Tanimura |
Organization
Tottori university
Division name
School of health sciences, Faculty of medicine
Zip code
683-8503
Address
86 Nishimachi, Yonago, Tottori
TEL
0859-38-6315
Homepage URL
chika01@med.tottori-u.ac.jp
Sponsor or person
Institute
International Platform for Dryland Research and Education(IPDRE)
Institute
Department
Personal name
Funding Source
Organization
International Platform for Dryland Research and Education(IPDRE)
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
Tottori University
Address
86 Nishimachi, Yonago, Tottori
Tel
0859-38-6315
chika01@med.tottori-u.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
146
Results
Hemoglobin A1c, self-efficacy, and self-management behaviors were found to affect physical quality of life, while hemoglobin A1c, neuropathy, insulin knowledge, self-efficacy, and self-management behaviors were found to affect mental quality of life.
Among the subjects, 13 peer leaders were selected to implement the peer support program (intervention). At 12 and 18 months after the intervention, participants' knowledge of diabetes was significantly increased compared with baseline (both P < 0.05).
Results date posted
| 2020 | Year | 04 | Month | 22 | Day |
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
Main results already published
Date of protocol fixation
| 2016 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 20 | Day |
Last modified on
| 2021 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031034
