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NCT05407454 Clinical Trial

Turkish Version of The Diabetes Quality of Life Brief Clinical Inventory Validity and Reliability

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Turkish Version of The Diabetes Quality of Life Brief Clinical Inventory Validity and Reliability

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05407454
Other study ID # BEU-21/11-1-E.1276
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 7, 2022
Est. completion date August 7, 2022

Study information
Verified date September 2022
Source Dokuz Eylul University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date August 7, 2022
Est. primary completion date July 7, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaire
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.

Locations
Country Name City State
Turkey Bitlis Eren University Bitlis

Sponsors (2)
Lead Sponsor Collaborator
Ilke KARA, PT Bitlis Eren University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary The Diabetes Quality of Life - Brief Clinical Inventory 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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