- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05407454
Turkish Version of The Diabetes Quality of Life Brief Clinical Inventory Validity and Reliability
September 12, 2022 updated by: İlke KARA, PT
This study aims to develop Turkish version of the Diabetes Quality of Life Brief Clinical Inventory (DQL-BCI) and to perform validity and reliability evaluations.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The study will be carried out in two phases: DQL-BCI will be translated into Turkish and adapted to the cultural context, and the reliability and validity of the Turkish version of DQL-BCI will be investigated.
The translation process will be performed in accordance with generally accepted international principles of translation and cultural adaptation of measurement tools.
At least 150 subjects with type 2 diabetes will complete the Turkish version of DQL-BCI, the EQ-5D-3L questionnaire and the SF-12 quality of life questionnaire.
The examination will provide information about the reliability and the construct validity of the studied tool.
Study Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bitlis, Turkey, 13000
- Bitlis Eren University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 61 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Aged between 18-65 years old with diabetes
Description
Inclusion Criteria:
- Aged between 18-65 years old
- Diagnosed with diabetes for one year or more (Type 1 or Type 2)
- Literacy
- Being on at least one anti-diabetes medication
Exclusion Criteria:
- Not willing to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Study Group
Patients with diabetes (all types)
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The original form of the Diabetes Quality of Life-Brief Clinical Inventory was first developed in 1999 to establish a valid and reliable form of diabetes-specific quality of life.
Inventory items were developed to address the issues that have the greatest impact on assessing patient self-care behaviors and satisfaction with diabetes care.
Items are ranked on a 5-point Likert scale and are in two general formats.
One format includes satisfaction with treatment and quality of life and is scored from 1 (very satisfied) to 5 (not very satisfied).
The second format includes the frequency of adverse effects of diabetes itself or diabetes treatment and offers response options from 1 (never) to 5 (always).
Therefore, higher scores on the DQL-BCI items and subscales include negative values indicating problem frequency or dissatisfaction.
In order to use the DQL scale more efficiently in clinics, Burroughs et al. organized the 15-item DQL-BCI in 2004.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Diabetes Quality of Life - Brief Clinical Inventory
Time Frame: 1 week
|
The questionnaire consists of 15 questions, with no grouping into subscales or domains.
Items are in two general formats.
The first format is about the frequency of negative impacts of diabetes or odiabetes treatment and provides response options from "never" to "all the time".
The second format is about the satisfaction with the treatment and QoL, and patients provide answers by selecting from "very satisfied" to "very dissatisfied".
Answers to each question correspond to a score of 1-5, and 1 is the lowest score of a given parameter and 5 is the highest.
The total score is the sum of scores of individual questions.
The scoring ranges from 15 (the worst assessment of QoL) to 75 points (the best assessment of QoL).
|
1 week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 7, 2022
Primary Completion (Actual)
July 7, 2022
Study Completion (Actual)
August 7, 2022
Study Registration Dates
First Submitted
June 2, 2022
First Submitted That Met QC Criteria
June 2, 2022
First Posted (Actual)
June 7, 2022
Study Record Updates
Last Update Posted (Actual)
September 14, 2022
Last Update Submitted That Met QC Criteria
September 12, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BEU-21/11-1-E.1276
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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