Enhanced diabetes-cardiovascular management through primary health care in Pakistan
| ISRCTN | ISRCTN23905886 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23905886 |
| Protocol serial number | HSLTLM11019 |
| Sponsor | University of Leeds - COMDIS-HSD (UK) |
| Funder | University of Leeds |
- Submission date
- 14/06/2012
- Registration date
- 09/08/2012
- Last edited
- 04/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
Association for Social Development
House No. 12
Street 48, F-7/4
Islamabad
44000
Pakistan
| asd@asd.com.pk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomized controlled trial with two arms |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | Enhanced diabetes-cardiovascular management through primary health care in Pakistan: a cluster randomized trial |
| Study objectives | 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(s) | 1. Ethics Committee University of Leeds, 20/02/2011, ref: HSLTLM11019 2. NBC-90 National Bioethics Committee, Pakistan, 30/04/2012 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. To compare the mean treatment success (attending and HbA1Ac < 7.5%, or FBG <7) |
| Completion date | 31/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 448 |
| Total final enrolment | 495 |
| Key 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) |
| Key exclusion criteria | 1. Those not giving consent for the study 2. Does not meet inclusion criteria |
| Date of first enrolment | 01/01/2012 |
| Date of final enrolment | 31/12/2016 |
Locations
Countries of recruitment
- Pakistan
Study participating centre
44000
Pakistan
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2018 | 04/11/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/11/2019: The following changes were made:
1. Publication reference added.
2. The final enrolment number was added from the reference.
31/03/2017: Plain English summary added.
