Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/06/2012
Date assigned
09/08/2012
Last edited
31/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. Pakistan ranks seventh among the global top ten countries with highest number of people with diabetes. The prevalence of type 2 diabetes above the age of 25 years is around 10%. About 20% and 30% of diabetics are expected to have associated hypertension (high blood pressure) and hypercholesteremia (high blood cholesterol). Currently primary health care identifies only about 10% of the estimated prevalent type 2 diabetes cases, and the quality of care being offered for diabetes and associated heart disease is far from satisfactory. A set of guidelines and materials with sound scientific evidence is required for expanding care delivery through strengthened primary care facilities. The aim of this study is to develop and test an intervention for delivering quality care to type 2 diabetes patients.

Who can participate?
Patients aged over 25 with type 2 diabetes

What does the study involve?
Participating primary healthcare facilities are randomly allocated to either enhanced case management of type 2 diabetes or routine type 2 diabetes case management. The care participants receive is the same whether they take part in the study or not. If they agree to take part their care records are used to assess the management services at the clinic for high blood pressure and associated illnesses. Participants have to come twice for a blood test, once at the start of the study and once at the end of study. This monitoring is free of charge.

What are the possible benefits and risks of participating?
The care participants receive is the same whether they take part in the study or not. If they take part they may have the usual or slightly different procedures (more information/data is taken if they take part in the study). The results will help to find the best way to care for patients like them in the future. There are no direct benefits to the patient, but this study hopes to improve the care of patients with high sugar levels and associated illnesses at private clinics in the country. There are no added risks involved in participating in this study,

Where is the study run from?
Pakistan, with the involvement of the University of Leeds (UK)

When is the study starting and how long is it expected to run for?
January 2012 to December 2016

Who is funding the study?
University of Leeds (UK)

Who is the main contact?
Dr Amir Khan
asd@asd.com.pk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Muhammad Amir Khan

ORCID ID

Contact details

Association for Social Development
House No. 12
Street 48
F-7/4
Islamabad
44000
Pakistan
-
asd@asd.com.pk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HSLTLM11019

Study information

Scientific title

Enhanced diabetes-cardiovascular management through primary health care in Pakistan: a cluster randomized trial

Acronym

Study hypothesis

How effective and feasible is it to achieve better glycemic control (primary) and BP/cholesterol control and adherence to appointments (secondary) among adult type 2 diabetes patients attending the strengthened primary health care facilities?

Ethics approval

1. Ethics Committee University of Leeds, 20/02/2011, ref: HSLTLM11019
2. NBC-90 National Bioethics Committee, Pakistan, 30/04/2012

Study design

Cluster randomized controlled trial with two arms

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Diabetes and cardiovascular disease

Intervention

Intervention arm:
Enhanced case management of type 2 diabetes patients through strengthening of primary healthcare facilities. The case management enhancement mainly includes:
1. Availability of context sensitive guidelines and materials for case management
2. Health staff trained on operational guidelines and materials
3. Supplement material support for managing type 2 diabetes and associated hypertension (and hyper-cholesterol) conditions
4. Standardized recording and reporting
5. Enhanced facility monitoring
6. Facilitated referral linkages with district head quarter hospital and
7. Better retrieval of patients with delayed follow-up visits

Control arm
The control for comparison is a routine set of activities for type 2 diabetes case management at primary health care facilities. The only addition will be
1. Enhanced screening and diagnosis
2. Introduction of Type 2 Diabetes-CVD register for collecting core data set on patients attending these control facilities
3. Drug supply ordering by DHO/RHC in a regular manner as before to the Rural Health Clinics (RHCs)
4. Introduction of a information leaflet which includes lifestyle modification and when/where to seek help in case of any complications

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Glycaemic control among registered Type 2 diabetes cases. The case registration will be taken mainly from the Type 2 diabetes care register at each facility.
2. The mean change in Hb1AC measurement, i.e change of mean HbA1c at 18 months of follow-up compared to the baseline (at registration), will be used for assessing the glycemic control.

Secondary outcome measures

1. To compare the mean treatment success (attending and HbA1Ac < 7.5%, or FBG <7)
2. To compare the mean hypertension control (< 130/80) and total cholesterol (<200) achieved in the adult Type 2 diabetes patients, with associated hypertension and hyper-cholesterol conditions
3. To conduct incremental cost effectiveness analysis of managing adult type 2 diabetes patients at Primary Health Care (PHC) facilities in Punjab, Pakistan
4. To inform the provincial strategic plan for managing type 2 diabetes and associated hypertension and hyper-cholesterol conditions in Punjab

Overall trial start date

01/01/2012

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. All type 2 diabetes patients of both genders, age > 25 years
2. Resident of the catchment area of the respective facility (RHC/tehsil hospital)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Total of 448 patients (224 in each arm) will be included in the study

Participant exclusion criteria

1. Those not giving consent for the study
2. Does not meet inclusion criteria

Recruitment start date

01/01/2012

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Pakistan

Trial participating centre

Association for Social Development
Islamabad
44000
Pakistan

Sponsor information

Organisation

University of Leeds - COMDIS-HSD (UK)

Sponsor details

Leeds Institute of Health Sciences
Charles Thackrah Building
101 Clarendon Road
Leeds
LS2 9LJ
United Kingdom
-
J.Walley@leeds.ac.uk

Sponsor type

University/education

Website

http://www.leeds.ac.uk/hsphr/research/NCIHD/comdis-hsd.html

Funders

Funder type

University/education

Funder name

University of Leeds

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

31/03/2017: Plain English summary added.