NCT05407454

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

June 7, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2022

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

1 month

First QC Date

June 2, 2022

Last Update Submit

September 12, 2022

Conditions

Keywords

DiabetesQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Study Group

Patients with diabetes (all types)

Other: Questionnaire

Interventions

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Aged between 18-65 years old with diabetes

You may qualify if:

  • 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

You may not qualify if:

  • Not willing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bitlis Eren University

Bitlis, 13000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-Principal Investigator

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 7, 2022

Study Start

June 7, 2022

Primary Completion

July 7, 2022

Study Completion

August 7, 2022

Last Updated

September 14, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations