Unique ID issued by UMIN | UMIN000031595 |
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Receipt number | R000035409 |
Scientific Title | Development and validation of new self-administered questionnaire regarding the quality of life (QOL) of continuous subcutaneous insulin infusion (CSII) |
Date of disclosure of the study information | 2018/03/06 |
Last modified on | 2019/10/25 13:48:15 |
Development and validation of new self-administered questionnaire regarding the quality of life (QOL) of continuous subcutaneous insulin infusion (CSII)
Development and validation of new self-administered questionnaire regarding the quality of life (QOL) of continuous subcutaneous insulin infusion (CSII) (CSII-QOL study)
Development and validation of new self-administered questionnaire regarding the quality of life (QOL) of continuous subcutaneous insulin infusion (CSII)
Development and validation of new self-administered questionnaire regarding the quality of life (QOL) of continuous subcutaneous insulin infusion (CSII) (CSII-QOL study)
Japan |
Type 1 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
To develop and validate new self-administered questionnaire regarding the quality of life (QOL) of continuous subcutaneous insulin infusion (CSII).
Others
Validity
Validity and reliability of new self-administered questionnaire regarding the quality of life (QOL) of continuous subcutaneous insulin infusion (CSII)
Relationship between CSII-QOL score and baseline measurements {HbA1c, age, sex, BMI, present history (diabetes duration, history of insulin therapy, history of CSII), type of insulin pump, insulin dosage (total daily dose, total basal dose), diabetic retinopathy, diabetic nephropathy, QOL (Problem Areas in Diabetes: PAID)}.
Observational
15 | years-old | <= |
Not applicable |
Male and Female
(1) Type 1 diabetes.
(2) Patients using insulin pump for no less than one year.
(3) Patients who regularly visit or being hospitalized at the medical institute participating this study.
(1) Type 2 diabetes.
(2) Patients who are not suitable to participate in this study for any other reasons.
50
1st name | Takashi |
Middle name | |
Last name | Murata |
NHO Kyoto Medical Center
Diabetes Center
612-8555
1-1 Fukakusamukaihatacho, Fushimi-ku, Kyoto, Kyoto, Japan
075-641-9161
murata-tky@umin.net
1st name | Takashi |
Middle name | |
Last name | Murata |
NHO Kyoto Medical Center
Diabetes Center
612-8555
1-1 Fukakusamukaihatacho, Fushimi-ku, Kyoto, Kyoto, Japan
075-641-9161
murata-tky@umin.net
NHO Kyoto Medical Center
Self-funding
Self funding
NHO Kyoto Medical Center, Ethics Committee
1-1 Fukakusamukaihatacho, Fushimi-ku, Kyoto, Kyoto, Japan
075-641-9161
yamaji.hirofumi.bg@mail.hosp.go.jp
NO
国立病院機構京都医療センター(京都府)(NHO Kyoto Medical Center, Kyoto)、徳島大学病院(徳島県)(Tokushima University, Tokushima)、東海大学医学部付属病院(神奈川県)(Tokai University School of Medicine, Kanagawa)、神戸大学医学部附属病院(兵庫県)(Kobe University Hospital, Hyogo)、国立病院機構大阪医療センター(大阪府)(NHO Osaka Medical Center, Osaka)、岡山大学病院(岡山県)( Okayama University Hospital, Okayama)、澤木内科・糖尿病クリニック(Sawaki Internal Medicine and Diabetes Clinic)
2018 | Year | 03 | Month | 06 | Day |
https://www.ncbi.nlm.nih.gov/pubmed/31638420
Published
https://www.ncbi.nlm.nih.gov/pubmed/31638420
50
The final 25-item questionnaire had a three-domain structure ("convenience", "social restriction", and "psychological problems"), high internal consistency (Cronbach's alpha = 0.870), and substantial test-retest reliability (intraclass correlation coefficient = 0.65). The CSII-QOL score was correlated negatively with the Problem Areas in Diabetes (PAID) score.
2019 | Year | 10 | Month | 25 | Day |
2019 | Year | 10 | Month | 22 | Day |
28% males; age, 47.6 years old.
The study participants responded twice to the self-reporting questionnaire at the interval of 1 week or more to less than 13 weeks.
N.A.
Validity and reliability of the new self-reporting questionnaire.
Completed
2018 | Year | 01 | Month | 31 | Day |
2015 | Year | 03 | Month | 16 | Day |
2018 | Year | 03 | Month | 06 | Day |
2018 | Year | 10 | Month | 12 | Day |
2018 | Year | 11 | Month | 09 | Day |
2018 | Year | 11 | Month | 09 | Day |
2019 | Year | 09 | Month | 26 | Day |
This study is aimed to validate the newly developed self-administrated questionnaire (CSII-QOL) to assess the quality of life (QOL) regarding continuous subcutaneous insulin infusion (CSII). After obtaining written informed consent, 50 subjects aged 15 years old or more are requested to fill in CSII-QOL questionnaire and Problem Areas in Diabetes (PAID) questionnaire. The subjects are requested to fill in the same questionnaire again after 1 week or more and before less than 13 weeks. The obtained information will be anonymized and be analyzed for the validity and reliability.
2018 | Year | 03 | Month | 05 | Day |
2019 | Year | 10 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035409
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