ANZCTR - Registration

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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]

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

Condition category

Condition code

Metabolic and Endocrine

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]

Lifestyle

Intervention code [2]

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]

HbA1c measured using serum assay

Timepoint [1]

six months

Secondary outcome [1]

(i) Diet: measured using Food Frequency Questionnaire

Timepoint [1]

six months

Secondary outcome [2]

(ii) Physical activity: measured using International Physical Activity Questionnaire (IPAQ)

Timepoint [2]

six months

Secondary outcome [3]

(iii) Blood pressure systolic and diastolic measured using a sphygmomanometer

Timepoint [3]

six months

Secondary outcome [4]

Lipid levels (LDL, HDL & TG) using serum assay

Timepoint [4]

six months

Secondary outcome [5]

Abdominal Adiposity: waist circumference and hip/waist ratio

Timepoint [5]

six months

Secondary outcome [6]

Self Efficacy: measured as Diabetes self efficacy (DES).

Timepoint [6]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Sri Lanka

State/province [1]

Western

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of New South Wales

Address [1]

Sydney
NSW 2052

Country [1]

Australia

Primary sponsor type

University

Name

University of New South Wales

Address

Sydney
NSW 2052

Country

Australia

Secondary sponsor category [1]

None

Name [1]

none

Address [1]

none

Country [1]

Other collaborator category [1]

University

Name [1]

Faculty of Medicine
University of Kelaniya

Address [1]

PO Box 6
Thallagolla road
Ragama
Sri Lanka

Country [1]

Sri Lanka

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee (HREC)

Ethics committee address [1]

Grants Management Office 
University of New South Wales 
Sydney
NSW 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

13/04/2010

Ethics approval number [1]

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

A/Prof Rohan Jayasuriya

Address

School of Public Health & Community Medicine
University of New South Wales
Sydney
NSW 2052

Country

Australia

Phone

+61413195448

Fax

[email protected]

Contact person for public queries

Name

Rohan Jayasuriya

Address

School of Public Health & Community Medicine
University of New South Wales
Sydney
NSW 2052

Country

Australia

Phone

+61413195448

Fax

[email protected]

Contact person for scientific queries

Name

Rohan Jayasuriya

Address

School of Public Health & Community Medicine
University of New South Wales
Sydney
NSW 2052

Country

Australia

Phone

+61413195448

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Translational research for Diabetes Self-Management in Sri Lanka: A randomized controlled trial.	2015	https://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.

Trial Review

Documents added manually

Documents added automatically