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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000031595 |
Receipt No. | 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 |
Basic information | ||
Public title | Development and validation of new self-administered questionnaire regarding the quality of life (QOL) of continuous subcutaneous insulin infusion (CSII) | |
Acronym | Development and validation of new self-administered questionnaire regarding the quality of life (QOL) of continuous subcutaneous insulin infusion (CSII) (CSII-QOL study) | |
Scientific Title | Development and validation of new self-administered questionnaire regarding the quality of life (QOL) of continuous subcutaneous insulin infusion (CSII) | |
Scientific Title:Acronym | Development and validation of new self-administered questionnaire regarding the quality of life (QOL) of continuous subcutaneous insulin infusion (CSII) (CSII-QOL study) | |
Region |
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Condition | ||
Condition | Type 1 diabetes mellitus | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To develop and validate new self-administered questionnaire regarding the quality of life (QOL) of continuous subcutaneous insulin infusion (CSII). |
Basic objectives2 | Others |
Basic objectives -Others | Validity |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Validity and reliability of new self-administered questionnaire regarding the quality of life (QOL) of continuous subcutaneous insulin infusion (CSII) |
Key secondary outcomes | 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)}. |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | (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. |
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Key exclusion criteria | (1) Type 2 diabetes.
(2) Patients who are not suitable to participate in this study for any other reasons. |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | NHO Kyoto Medical Center | ||||||
Division name | Diabetes Center | ||||||
Zip code | 612-8555 | ||||||
Address | 1-1 Fukakusamukaihatacho, Fushimi-ku, Kyoto, Kyoto, Japan | ||||||
TEL | 075-641-9161 | ||||||
murata-tky@umin.net |
Public contact | |||||||
Name of contact person |
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Organization | NHO Kyoto Medical Center | ||||||
Division name | Diabetes Center | ||||||
Zip code | 612-8555 | ||||||
Address | 1-1 Fukakusamukaihatacho, Fushimi-ku, Kyoto, Kyoto, Japan | ||||||
TEL | 075-641-9161 | ||||||
Homepage URL | |||||||
murata-tky@umin.net |
Sponsor | |
Institute | NHO Kyoto Medical Center |
Institute | |
Department |
Funding Source | |
Organization | Self-funding |
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 | NHO Kyoto Medical Center, Ethics Committee |
Address | 1-1 Fukakusamukaihatacho, Fushimi-ku, Kyoto, Kyoto, Japan |
Tel | 075-641-9161 |
yamaji.hirofumi.bg@mail.hosp.go.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 | 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) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | https://www.ncbi.nlm.nih.gov/pubmed/31638420 |
Publication of results | Published |
Result | |||||||
URL related to results and publications | https://www.ncbi.nlm.nih.gov/pubmed/31638420 | ||||||
Number of participants that the trial has enrolled | 50 | ||||||
Results | 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.
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Results date posted |
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Results Delayed | |||||||
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Baseline Characteristics | 28% males; age, 47.6 years old. | ||||||
Participant flow | The study participants responded twice to the self-reporting questionnaire at the interval of 1 week or more to less than 13 weeks. | ||||||
Adverse events | N.A. | ||||||
Outcome measures | Validity and reliability of the new self-reporting questionnaire. | ||||||
Plan to share IPD | |||||||
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
Other related information | 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. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035409 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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