Diabetes MellitusNCT05407454
Turkish Version of The Diabetes Quality of Life Brief Clinical Inventory Validity and Reliability
An observational study of Diabetes Mellitus and Diabetes Mellitus, Type 1, run by İlke KARA, PT at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- Questionnaire
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jun 2022to 7 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Aged between 18-65 years old with diabetes
Who may be able to join
- 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
Who cannot join
- Not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Questionnaire
- Keywords
- Diabetes, Quality of Life
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Patients with diabetes (all types) Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start7 Jun 2022
- Primary completion7 Jul 2022
- Study completion7 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- İlke KARA, PT
- Sponsor type
- University, hospital or other
- Collaborators
- Bitlis Eren University
- Responsible party
- Sponsor-investigator, İlke KARA, PT, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407454
- Sponsor's protocol ID
- BEU-21/11-1-E.1276
- Status last verified
- Sep 2022
- First submitted
- 2 Jun 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Version of The Diabetes Quality of Life Brief Clinical Inventory Validity and Reliability
- ClinicalTrials.gov ID
- NCT05407454
- Acronym / sponsor ID
- BEU-21/11-1-E.1276
- Keywords
- Diabetes, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- İlke KARA, PTUniversity, hospital or other
- Collaborators
- Bitlis Eren University
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Aug 2022 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: QuestionnairePatients with diabetes (all types) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Aged between 18-65 years old with diabetes
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Not willing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireThe 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. | Other | Study Group |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Diabetes Mellitus, Type 1, run by İlke KARA, PT at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Diabetes Quality of Life - Brief Clinical Inventory (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.