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

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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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name