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Randomized Controlled Trial
. 2010 Dec 1:341:c6387.
doi: 10.1136/bmj.c6387.

Community based integrated intervention for prevention and management of chronic obstructive pulmonary disease (COPD) in Guangdong, China: cluster randomised controlled trial

Yumin Zhou  1 , Guoping Hu, Dali Wang, Shaoyi Wang, Yujun Wang, Zhigang Liu, Jinxin Hu, Zhe Shi, Gongyong Peng, Shengming Liu, Jiachun Lu, Jingping Zheng, Jian Wang, Nanshan Zhong, Pixin Ran
Affiliations
Randomized Controlled Trial

Community based integrated intervention for prevention and management of chronic obstructive pulmonary disease (COPD) in Guangdong, China: cluster randomised controlled trial

Yumin Zhou et al. BMJ. .

Abstract

Objective: To evaluate the effects of a community based integrated intervention for early prevention and management of chronic obstructive pulmonary disease (COPD) in China.

Design: Cluster randomised controlled trial.

Setting: Eight healthcare units in two communities.

Participants: Of 1062 people aged 40-89, 872 (101 with COPD and 771 without COPD) who fulfilled the inclusion and exclusion criteria were allocated to the intervention or the usual care programmes.

Intervention: Participants randomly assigned to integrated intervention (systematic health education, intensive and individualised intervention, treatment, and rehabilitation) or usual care.

Main outcome measures: Annual rate of decline in forced expiratory rate in one second (FEV(1)) before use of bronchodilator.

Results: Annual rate of decline in FEV(1) was significantly lower in the intervention community than the control community, with an adjusted difference of 19 ml/year (95% confidence interval 3 to 36) and 0.9% (0.1% to 1.8%) of predicted values (all P<0.05), as well as a lower annual rate of decline in FEV(1)/FVC (forced vital capacity) ratio (adjusted difference 0.6% (0.1% to 1.2%) P=0.029). There were also higher rates of smoking cessation (21% v 8%, P<0.004) and lower cumulative death rates from all causes (1% v 3%, P<0.009) in the intervention community than in the control community during the four year follow-up. Improvements in knowledge of COPD and smoking hazards, outdoor air quality, environmental tobacco smoke, and working conditions were also achieved (all P<0.05). The difference in cumulative incidence rate of COPD (both around 4%) and cumulative death rate from COPD (2% v 11%) did not reach significance between the two communities.

Conclusions: A community based integrated intervention can have a significant impact on the prevention and management of COPD, mainly reflected in the annual rate of decline in FEV(1).

Trial registration: Chinese Clinical Trials Registration (ChiCTR-TRC-00000532).

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Conflict of interest statement

Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any institution for the submitted work; no financial relationships with any institutions that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

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Fig 1 Flow of participants through trial. Missing indicates participants with missing data because of failure of contact, being out, or inability to finish spirometry test; they might attend next follow-up visits. Withdrew indicates cumulative number of participants who withdrew consent (refusal); they were invited to complete investigation with questionnaire before dropping out
None
Fig 2 Annual log mean levels of air pollutants in intervention and control communities, 2002-2007, with 95% confidence intervals
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Fig 3 Estimated mean FEV1 (ml and % predicted) and FEV1/FVC ratio (%) over time in both communities among total population and those without COPD. *P<0.05 for estimated mean after adjustment for clustering and confounding factors (baseline FEV1 (or FEV1/FVC ratio), age, sex, education, smoking status, environmental tobacco smoke, COPD, BMI, and occupational exposure to dust/gases/fumes). P values in figure refer to comparison between communities in rate of decline in FEV1 and FEV1/FVC ratio after adjustment for above confounders and clustering effects
See this image and copyright information in PMC

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