Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000724178
Ethics application status
Approved
Date submitted
10/05/2019
Date registered
14/05/2019
Date last updated
18/09/2019
Date data sharing statement initially provided
14/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Subthreshold depression and self-care behaviour in adults with type 2 diabetes
Scientific title
Association between subthreshold depression and self-care behaviours in adults with type 2 diabetes: a cross-sectional survey
Secondary ID [1] 298174 0
Nil known
Universal Trial Number (UTN)
U1111-1233-1580
Trial acronym
SubSCD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subthreshold depression 312741 0
Self-care behaviour 312765 0
Condition category
Condition code
Metabolic and Endocrine 311236 311236 0 0
Diabetes
Mental Health 311267 311267 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Subthreshold depression in adults with type 2 diabetes. The participants will be recruited from the diabetes outpatient clinic in a tertiary health care facility. After receiving the consent from the participants, they will be invited for the interview. The interview will take approximately 30 minutes to complete.
Intervention code [1] 314414 0
Not applicable
Comparator / control treatment
Type 2 diabetes adults with no depression.
Control group
Active

Outcomes
Primary outcome [1] 320006 0
Mean number of days of diabetes self-care behaviour measured using Nepalese version of "summary of Diabetes Self-care Activities (SDSCA)". SDSCA measures the frequency of diabetes self-care tasks over the past seven days in five domains: diet, exercise, blood sugar testing, foot care and medication adherence.
Timepoint [1] 320006 0
At the time of the survey.
Secondary outcome [1] 370206 0
Proportion of subthreshold depression determined using the "Patient Health Questionnaire-9 (PHQ-9)". PHQ-9 is 9 item questionnaire that asks participants to specify how often, during the past two weeks, they had been affected by the various depression symptoms. Those adults who score PHQ-9 between 5-9 will be classified as having subthreshold depression.
Timepoint [1] 370206 0
At the time of the survey.

Eligibility
Key inclusion criteria
Participants will be included in the study if they are: 1) 18 years of age or older, 2) diagnosed with type 2 diabetes for at least one year and 3) willing to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The participants are excluded in the study if they are: 1) diagnosed with type 1 diabetes, gestational diabetes, or other specific types of diabetes, 2) they have a history of severe mental illness (e.g. Schizophrenia, bipolar) or 3) they have severe cognitive and language deficit.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Statistical methods / analysis
Descriptive statistics will be used to summarise the key characteristics of the sample. The bivariate analysis will be done using the chi-square test to compare the characteristics of the patients with type 2 diabetes by subthreshold depression status. Multivariate analysis using multiple linear regression test will be done to check the independent association between subthreshold depression and self-care behaviour by adjusting the confounders.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/07/2019
Actual
2/08/2019
Date of last participant enrolment
Anticipated
30/12/2019
Actual
Date of last data collection
Anticipated
30/12/2019
Actual
Sample size
Target
384
Accrual to date
120
Final
Recruitment outside Australia
Country [1] 21460 0
Nepal
State/province [1] 21460 0
Province 3

Funding & Sponsors
Funding source category [1] 302709 0
University
Name [1] 302709 0
La Trobe University
Country [1] 302709 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
School of Nursing and Midwifery, George Singer Building, Level 3, Bundoora, VIC 3086, Australia
Country
Australia
Secondary sponsor category [1] 302656 0
None
Name [1] 302656 0
Address [1] 302656 0
Country [1] 302656 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303319 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 303319 0
Ethics committee country [1] 303319 0
Australia
Date submitted for ethics approval [1] 303319 0
18/02/2019
Approval date [1] 303319 0
11/04/2019
Ethics approval number [1] 303319 0
HEC19067
Ethics committee name [2] 304362 0
Nepal Health Research Council
Ethics committee address [2] 304362 0
Ethics committee country [2] 304362 0
Nepal
Date submitted for ethics approval [2] 304362 0
23/04/2019
Approval date [2] 304362 0
12/06/2019
Ethics approval number [2] 304362 0
3209

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93258 0
Prof Richard Gray
Address 93258 0
School of Nursing and Midwifery
George Singer Building, Level 3
Bundoora, VIC 3086
Australia
Country 93258 0
Australia
Phone 93258 0
+61394796743
Fax 93258 0
Email 93258 0
[email protected]
Contact person for public queries
Name 93259 0
Monika Shrestha
Address 93259 0
School of Nursing and Midwifery
George Singer Building, Level 3
Bundoora, VIC 3086
Australia
Country 93259 0
Australia
Phone 93259 0
+61 416920678
Fax 93259 0
Email 93259 0
[email protected]
Contact person for scientific queries
Name 93260 0
Monika Shrestha
Address 93260 0
School of Nursing and Midwifery
George Singer Building, Level 3
Bundoora, VIC 3086
Australia
Country 93260 0
Australia
Phone 93260 0
+61 416920678
Fax 93260 0
Email 93260 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.