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Trial registered on ANZCTR


Registration number
ACTRN12613000208707
Ethics application status
Approved
Date submitted
6/02/2013
Date registered
21/02/2013
Date last updated
21/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the feasibility of a patient-centered intervention for diabetes self-management in Sri Lanka
Scientific title
Diabetes Self management versus usual care for reaching Glycaemia targets
Secondary ID [1] 281908 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type two Diabetes Mellitus 288307 0
Condition category
Condition code
Metabolic and Endocrine 288662 288662 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A nurse-led, face to face , one-on-one intervention, consisting of an intervention phase of four weekly sessions of 1 hour each and a maintenance phase with follow up sessions of 30 minutes every month to reinforce behaviour change for 6 months. We focused on patient empowerment, through collaborative goal setting and action planning to enhance self management skills using techniques of brief Motivational Interviewing , goal setting, problem solving and action planning.
Intervention code [1] 286475 0
Lifestyle
Intervention code [2] 286561 0
Behaviour
Comparator / control treatment
The control group received standard monthly clinic visits and group patient education provided at the clinic.
Control group
Active

Outcomes
Primary outcome [1] 288808 0
HbA1c measured using serum assay
Timepoint [1] 288808 0
six months
Secondary outcome [1] 301043 0
(i) Diet: measured using Food Frequency Questionnaire
Timepoint [1] 301043 0
six months
Secondary outcome [2] 301311 0
(ii) Physical activity: measured using International Physical Activity Questionnaire (IPAQ)
Timepoint [2] 301311 0
six months
Secondary outcome [3] 301312 0
(iii) Blood pressure systolic and diastolic measured using a sphygmomanometer
Timepoint [3] 301312 0
six months
Secondary outcome [4] 301313 0
Lipid levels (LDL, HDL & TG) using serum assay
Timepoint [4] 301313 0
six months
Secondary outcome [5] 301314 0
Abdominal Adiposity: waist circumference and hip/waist ratio
Timepoint [5] 301314 0
six months
Secondary outcome [6] 301315 0
Self Efficacy: measured as Diabetes self efficacy (DES).
Timepoint [6] 301315 0
six months

Eligibility
Key inclusion criteria
1. Cases of T2DM attending the Diabetes clinic for the first time but diagnosed within the last five years ;
2. Live within 10 kilometers of the clinic
3. Aged greater than or equal to 40 years and less than 70 years;
4. Confirmed T2DM based on Fasting Plasma Glucose of >140 mg/dl [7 mmol/L] or 2-hour post-glucose glucose of 11.1mmol/L (Sri Lanka Clinical guidelines)(ref);
5. Did not have any diabetic complications, have no history of cardiovascular disease and any serious illness;
6. Currently obtain oral therapy and/or insulin from a regular source (provided free of cost at public hospitals ) or have private means to purchase regular medication;
7. Willing for randomization.
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pregnancy, have a serious illness, mental illness, cancer diagnosis in the last five years, or other conditions that may impede or prohibit participation.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A computer generated algorithm was used by a researcher (not directly involved in the project) to randomize the patients with the treatment allocation of patients. Those allocated to the intervention were given an appointment to be seen by the intervention staff ( medical officer and trained nurses). Those on the control arm continued to attend the regular monthly clinic.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participants in the intervention and control were compared on all demographic, biochemical, lifestyle and psychological measures using t-tests or non parametric tests as appropriate. Data missing from complete questionnaires were excluded from analysis and indicated by reduction of sample size. Effectiveness of intervention was analyzed using analysis of covariance .

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/04/2010
Actual
3/05/2010
Date of last participant enrolment
Anticipated
30/06/2010
Actual
5/07/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment outside Australia
Country [1] 4853 0
Sri Lanka
State/province [1] 4853 0
Western

Funding & Sponsors
Funding source category [1] 286698 0
University
Name [1] 286698 0
University of New South Wales
Country [1] 286698 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Sydney
NSW 2052
Country
Australia
Secondary sponsor category [1] 285469 0
None
Name [1] 285469 0
none
Address [1] 285469 0
none
Country [1] 285469 0
Other collaborator category [1] 277273 0
University
Name [1] 277273 0
Faculty of Medicine
University of Kelaniya
Address [1] 277273 0
PO Box 6
Thallagolla road
Ragama
Sri Lanka
Country [1] 277273 0
Sri Lanka

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288764 0
Human Research Ethics Committee (HREC)
Ethics committee address [1] 288764 0
Grants Management Office
University of New South Wales
Sydney
NSW 2052
Ethics committee country [1] 288764 0
Australia
Date submitted for ethics approval [1] 288764 0
Approval date [1] 288764 0
13/04/2010
Ethics approval number [1] 288764 0
HC10025

Summary
Brief summary
A feasibility trial of a patient centered self management intervention for type two diabetes was conducted in Ragama, Sri Lanka
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37670 0
A/Prof Rohan Jayasuriya
Address 37670 0
School of Public Health & Community Medicine
University of New South Wales
Sydney
NSW 2052
Country 37670 0
Australia
Phone 37670 0
+61413195448
Fax 37670 0
Email 37670 0
[email protected]
Contact person for public queries
Name 37671 0
A/Prof Rohan Jayasuriya
Address 37671 0
School of Public Health & Community Medicine
University of New South Wales
Sydney
NSW 2052
Country 37671 0
Australia
Phone 37671 0
+61413195448
Fax 37671 0
Email 37671 0
[email protected]
Contact person for scientific queries
Name 37672 0
A/Prof Rohan Jayasuriya
Address 37672 0
School of Public Health & Community Medicine
University of New South Wales
Sydney
NSW 2052
Country 37672 0
Australia
Phone 37672 0
+61413195448
Fax 37672 0
Email 37672 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseTranslational research for Diabetes Self-Management in Sri Lanka: A randomized controlled trial.2015https://dx.doi.org/10.1016/j.pcd.2015.01.014
N.B. These documents automatically identified may not have been verified by the study sponsor.