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Trial registered on ANZCTR


Registration number
ACTRN12617001327370
Ethics application status
Approved
Date submitted
15/08/2017
Date registered
15/09/2017
Date last updated
16/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of pharmacist based educational program on glycaemic control, self-care activities and disease knowledge in type 2 diabetes patients in Pakistan.
Scientific title
A randomised controlled study to evaluate the effect of pharmacist led educational intervention on glycaemic control, self-care activities and disease knowledge among type 2 diabetes patients.
Secondary ID [1] 292663 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
Linked study record
NIL

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus 304403 0
Condition category
Condition code
Metabolic and Endocrine 303732 303732 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomized controlled trail (RCT) will be conducted at diabetes clinic of Capital Development Authority (CDA) hospital, located in Islamabad, Pakistan. Overall eighty (80) T2DM patients, with poorly controlled diabetes (HbA1c> 7%) will be randomized into intervention (N=40) and control groups (N=40). A baseline assessment for patients of both groups will be done for their self-care activities and disease knowledge by using validated Urdu versions of Diabetes Self-management Questionnaire (DSMQ) and Diabetes Knowledge Questionnaire (DKQ), respectively. After the baseline evaluation, interventional group patients will be supplemented with a face to face pharmacist-led educational intervention (60 min duration). The educational intervention and patient informatory material has been designed according to American diabetes Association (ADA) guidelines and validated after detailed conversation with the field experts. A qualified pharmacist (researcher) will educate the patients in the interventional group about disease (diabetes), its symptoms, clinical goals, self-care activities (self-monitoring of blood glucose, physical activity, importance of regular medication in-take and healthy diet), and, reducing risks. Patients in the intervention group will be educated by pharmacist with the help of presentation, informatory brochures and pictograms. During 24 weeks of study, interventional group participants will be required to improve their self-care activities and in order to keep track of self-monitoring blood glucose they will also be provided log books to keep the record of their self-monitored blood glucose levels during this intervention period. Intervention group patients will be educated again at their first follow visit (12th week) for their self-care activities and any barrier (s) / problem (s) towards their self-care will be discussed (30 min duration). Additionally a brief telephonic follow-up by the pharmacist will be carried out for each patient four times during these 6 months intervention (at week 4,8,16 and 20). Whereas the control group patients (N=40) will receive the usual medical care. The researcher will use the interactive discussion strategy to enhance intervention group patients’ motivation to improve diabetes self-care behaviours. Final assessments for glycaemic control (HbA1c), self-care activities and disease knowledge, will be conducted at the end of trail (24th week) for both intervention and control groups. A brief educational programs’ satisfaction survey will be carried out at the end of the intervention (24th week) from the intervention arm participants.
Intervention code [1] 298898 0
Lifestyle
Intervention code [2] 298899 0
Behaviour
Comparator / control treatment
The control group will receive the usual care, which include a combination of medical treatment, physician monitoring and an optional counselling session about diabetes. The control group will be in waiting list to get the intervention which will be provided at the end of the study after post test data collection. That is, they will receive the intervention 6 months after enrolment.
Control group
Active

Outcomes
Primary outcome [1] 303101 0
Change in the HbA1c
Timepoint [1] 303101 0
Baseline, and at 6 months after intervention commencement
Primary outcome [2] 303102 0
Change in the diabetes self-care activities.
The Diabetes Self-management Questionnaire (DSMQ) will be used to measure the patient’s self-care activities (validated Urdu version).
Timepoint [2] 303102 0
Baseline, and at 6 months after intervention commencement
Secondary outcome [1] 337890 0
Patients knowledge about diabetes.
Diabetes Knowledge Questionnaire (DKQ), developed for the Starr County Diabetes Education Study, has been translated and validated in Urdu language in Pakistan.
Reference: Bukhsh A, Lee SWH, Pusparajah P, Khan AH and Khan TM (2017) Psychometric Properties of the Urdu Version of Diabetes Knowledge Questionnaire. Front. Public Health 5:139.
Timepoint [1] 337890 0
Baseline, and at 6 months after intervention commencement
Secondary outcome [2] 337891 0
Body mass index
Timepoint [2] 337891 0
Baseline, and at 6 months after intervention commencement

Eligibility
Key inclusion criteria
Includes poorly controlled (HbA1c>7%) T2DM, adult patients (age more than or equal to 30 years) regardless of gender; speak and understand Urdu and / or English language (s) ; having no significant co-morbidity; not being involved in any trial / study related to diabetes during last 3 months and able to attend regular visits
Minimum age
30 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they are of other types of diabetes (gestational diabetes, T1DM); age less than 30 years; unable to answer the questionnaire independently or having hearing, vision or cognitive impairments.

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)
Patients handpick a numbered envelope from the basket
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple random technique will be used form a list of random numbers of eligible patients which will be compiled by using the patients’ hospital identification numbers. After recruitment, the patients will be requested to handpick an envelope from the basket indicating allocation to either control or intervention group with 1:1 randomisation.
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)
Statistical methods / analysis
The analyses will performed using SPSS 22.0.0 (SPSS Inc., Chicago, IL, USA). Frequencies and descriptive statistics will be used for patients’ demographic presentation, while means and standard deviations will be calculated for the continuous variables and group differences will be analysed by using Pearson chi-square test for categorical variables, independent t test for continuous variables, and Mann-Whitney U-test for ordinal variables or non-normal distributions. Primary outcome of the educational intervention on HbA1C levels, self-care activities scores (DSMQ) and disease knowledge scores (DKQ) will be analysed by using analysis of variance (ANOVA). Paired t test will be used to analyze within group effects. The effects of the intervention will be examined in multivariate general linear models. P values <.05 will be considered as significant for all analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9148 0
Pakistan
State/province [1] 9148 0
PUNJAB

Funding & Sponsors
Funding source category [1] 297298 0
University
Name [1] 297298 0
Monash University Malaysia
Address [1] 297298 0
?Jalan Lagoon Selatan, 47500 Bandar Sunway, Selangor Darul Ehsan,
MALAYSIA
Country [1] 297298 0
Malaysia
Primary sponsor type
University
Name
Monash University Malaysia
Address
Jalan Lagoon Selatan, 47500 Bandar Sunway, Selangor Darul Ehsan
Country
Malaysia
Secondary sponsor category [1] 296270 0
Hospital
Name [1] 296270 0
Capital Development Authority Hospital, Islamabad
Address [1] 296270 0
CDA Hospital, St# 31, G-6/2, Islamabad
Country [1] 296270 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298406 0
Research and Ethics Committee, CDA, Hospital, Islamabad
Ethics committee address [1] 298406 0
CDA Hospital, St# 31, G-6/2, Islamabad
Ethics committee country [1] 298406 0
Pakistan
Date submitted for ethics approval [1] 298406 0
15/07/2017
Approval date [1] 298406 0
08/08/2017
Ethics approval number [1] 298406 0
CDA-077-2017

Summary
Brief summary
This study aims to examine the impact of a face to face short term (6 months) pharmacist-led educational intervention model in poorly controlled T2DM patient (HbA1c >7%) in Pakistan. In this study we will investigate the mean change in HbA1C at 6 months after the baseline, and a comparison will be made with a similar comparator group of T2DM patients who will not be provided education intervention. In addition comparison between self-care activities and disease knowledge between the groups will also be studied.
Trial website
NIL
Trial related presentations / publications
NIl
Public notes
NIL

Contacts
Principal investigator
Name 76986 0
Dr Tahir Mehmood Khan
Address 76986 0
School of Pharmacy, MONASH University, Jalan Lagoon Selatan, 47500 Bandar Sunway, Selangor Darul Ehsan, MALAYSIA
Country 76986 0
Malaysia
Phone 76986 0
+603 5514 6364
Fax 76986 0
+603 5514 6364
Email 76986 0
tahir.mehmood@monash.edu
Contact person for public queries
Name 76987 0
Mr Allah Bukhsh
Address 76987 0
School of Pharmacy, MONASH University, Jalan Lagoon Selatan, 47500 Bandar Sunway, Selangor Darul Ehsan, MALAYSIA
Country 76987 0
Malaysia
Phone 76987 0
+601133623703
Fax 76987 0
+603 5514 6364
Email 76987 0
allah.bukhsh@monash.edu
Contact person for scientific queries
Name 76988 0
Dr Tahir Mehmood Khan
Address 76988 0
School of Pharmacy, MONASH University, Jalan Lagoon Selatan, 47500 Bandar Sunway, Selangor Darul Ehsan, MALAYSIA
Country 76988 0
Malaysia
Phone 76988 0
+601127640646
Fax 76988 0
+603 5514 6364
Email 76988 0
tahir.mehmood@monash.edu

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary