Condition category
Respiratory
Date applied
03/04/2013
Date assigned
30/05/2013
Last edited
19/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
We are carrying out a study for strengthening the delivery of asthma and chronic obstructive pulmonary disease (COPD) care at primary health care (PHC) facilities already supporting tuberculosis (TB) care in Pakistan. The aim is to deliver quality asthma and COPD care through primary health care facilities in Pakistan.

Who can participate?
The eligible asthma and COPD patients of both genders, aged eighteen and above in the catchment area of the given health facility will be recruited in the study. A total of 428 asthma and 306 COPD patients will be recruited .

What does the study involve?
The proposed study will help to improve access to and quality of care for common lung health conditions, especially in underserved population i.e. rural areas. This will be done mainly by developing, testing and refining packages of essential curative and preventive services for asthma and COPD, through primary health care. This covers both the delivery and management support dimensions of quality care. We will compare the control of asthma and COPD achieved in the patients receiving quality lung health care (i.e. using standardised evidence-based guideline and materials) in comparison with the disease control for those receiving routine care at the PHC facilities. The asthma control and COPD control will be measured at baseline (beginning of the study) and 6 and 12 months after the start of treatment. The proposed research on care of asthma and COPD conditions will cover: a) enhanced screening and diagnosis, b) standardized prescription, c) interactive education of patient and family, d) follow-up and adherence, e) referral linkage with respective district hospital, f) district health office engagement and support, and g) technical support for in-country research uptake.

What are the possible benefits and risks of participating?
Participants:
Free diagnosis and treatment as per standardized clinical guidelines: Though routine drugs for the asthma and COPD are mentioned in the Drug list of the primary health care facilities - Rural Health Centre (RHC), they are not always present given the scarce resource setting. RHCs will be strengthened in this reference, to an extent possible, in the intervention arm.
The control arm patients will receive the current best practice, whereas intervention arm will receive enhanced care. Only nationally approved diagnostic and drugs will be used. The trial protocols will not expose patients to any additional risk.
Society:
Two districts with an estimated population of 2.5 million living in rural and semi-urban localities [including 18 RHCs and Tehsil headquarter hospitals (THQs)] will be enabled to manage and sustain quality care for asthma and COPD. These services will continue even after the trial, through respective district health office and potentially benefit thousands of diabetics in the district.
At least 214 asthma and 153 COPD cases (in the intervention arm) will receive enhanced lung care.
A set of case management desk guide, training package, patient education materials, and recording/reporting/monitoring system for lung health care will be potentially used in all 135 districts of Pakistan:
Sound scientific evidence for programmatic decision making in Pakistan (and elsewhere).
There are no adverse effects of the trial itself but there may be expected side effects of certain drugs that are used in the Asthma- COPD management package. To decrease this risk to the minimal only approved drugs will be used. The trial protocols will not expose patients to any additional risk.

Where is the study run from?
The study will run from 18 rural health centres (RHCs) and sub-district hospitals in districts Rawalpindi and Islamabad.

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

Who is funding the study?
The study is funded by COMDIS Health Service Delivery Research Programme Consortium (COMDIS-HSD), The University of Leeds UK and is being implemented by Association for Social Development in Pakistan.

Who is the main contact?
Dr. Muhammad 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
+92 (0)51 2611 230 33
asd@asd.com.pk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Strengthening the delivery of asthma and chronic obstructive pulmonary disease (COPD) care at primary health care facilities - a randomised controlled trial in Pakistan

Acronym

Study hypothesis

How effective and feasible is it to achieve better asthma and COPD control among adult patients (i.e. >18 years) attending the primary health care facilities already strengthened for Tuberculosis (TB) care?

Ethics approval

1. University of Leeds Research Ethics Committee, 22/01/2013, ref: HSLTLM/12/025
2. National Bioethics Committee, 20/03/2013, ref: 4-87/NBC-111/13/RDC/4682

Study design

Pragmatic cluster randomized controlled trial

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 below to request a patient information sheet

Condition

Asthma and Chronic Obstructive Pulmonary Disease (COPD)

Intervention

Intervention arm:
Quality care will be delivered to adult asthma and COPD patients, through enabled primary healthcare facilities already strengthened for TB care.
The inputs for delivering quality care will include:
1. Context sensitive case management and operational guidelines
2. Supplement equipment
3. Ensure un-interrupted supply of drugs
4. Training and supervisory support
5. Interactive patient education materials

The care delivery dimensions to be addresses will include:
1. Enhanced screening and diagnosis
2. Standardized prescription
3. Interactive education of patient and family
4. Follow up and adherence
5. Standardised recording, reporting and monitoring
6. Referral linkage with respective district hospital
7. District health office engagement and support
8. Technical support for in country research uptake

Control arm:
The control for comparison is a routine set of activities for asthma and COPD case management at primary health care facilities. The only addition will be:
1. Introduction of standard diagnosis and recording practices for asthma/COPD patients attending these control facilities.
2. Continued provision of essential drugs (at current level), through the district health office.

The routine set of activities – on the basis of early service review – are:
1. Varied diagnostic and prescription practices, as per individual doctor.
2. Salbutamol, corticosteroids, and antibiotic tablet/injection are available, with occasional interruption.
3. Currently patients are provided with 2-3 day drugs.
4. Record keeping is limited to OPD register only.
5. Late patient retrieval is not currently practiced.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Asthma
The control of asthma is measured as Forced Expiratory Volume/Forced Vital Capacity (FEV1/FVC) ratio > 0.75 in an individual patient.
Trained facility staff, at the start and then after 6 and 12 months of treatment, will assess the outcome in an individual patient.

2. COPD
The control of COPD is measured as the stable or an improved BODE index in an individual patient. The dimensions included are: Body Mass Index (BMI – kg/m2), Obstruction (FEV1/FVC ratio), Dyspnoea (assessed on MRC scale), and Exercise capacity (6 minute walk). Trained facility staff, at the start and then after 6 and 12 months of treatment, will assess the index in an individual patient. The mean difference between intervention and control arms will be at least one score on BODE index.

Secondary outcome measures

1. Secondary outcome measures to indicate utilization and quality of asthma and COPD care will be selected, through Technical Work Group process, for comparing the intervention and control arms. The examples of such indicators to consider are complications, adherence, etc.
2. Another secondary outcome will be incremental cost effectiveness to manage asthma and COPD in intervention as compared to the control arms.

Overall trial start date

01/10/2012

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. All newly diagnosed cases of asthma and COPD who have given the consent to participate in the trial
2. Male and female patients aged 18 years or more from the catchment population of the respective facility

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

A total of 428 asthma and 306 COPD patients will be recruited in 18 trial clusters (i.e. 24 and 17 patients/cluster respectively).

Participant exclusion criteria

1. Persons less than 18 years old
2. Persons not giving consent for the study
3. Persons having contraindication for trial procedures (e.g. people not fit for 6 minute walk, advanced or complicated cases as per stage IV of National Institute for Health and Care Excellence (NICE) / Global Initiative for Chronic Obstructive Lung Disease (GOLD)]

Recruitment start date

01/10/2012

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
+44 (0)113 343 4838
A.James@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

COMDIS-HSD – Research Programme Consortium, University of Leeds (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26578109

Publication citations

Additional files

Editorial Notes