Strengthening the delivery of asthma and chronic obstructive pulmonary disease (COPD) care at primary health care facilities

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17409338

Enrollment

734

Registered

2013-05-30

Start date

2012-10-01

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma and Chronic Obstructive Pulmonary Disease (COPD) Respiratory Asthma, unspecified, Chronic obstructive pulmonary disease, unspecified

Interventions

Intervention arm: Quality care will be delivered to adult asthma and COPD patients, through enabled primary healthcare facilities already strengthened for TB care. The

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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)]

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Pakistan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026