A longitudinal prospective multicentre cohort study on the effect of Geriatric Rehabilitation in patients with severe COPD admitted to the hospital with an acute exacerbation

Rationale: In view of the worldwide aging population, disease-specific geriatric rehabilitation (GR) programs are needed. One field in which development of disease-specific GR programs can be meaningful is progressive organ failure, such as chronic obstructive pulmonary disease (COPD). Prevalence of COPD is rising worldwide and disease severity is strongly related to age. Patients with advanced COPD suffer from a high symptom burden, deteriorating functional capacity and declining quality of life; moreover, their prognosis is poor, especially after hospital admission for an acute exacerbation. Therefore, we developed and implemented a post-acute GR program for patients with severe COPD, the GR-COPD program. We then conducted a pilot study to investigate the feasibility of the GR-COPD program and to present clinical data on patient characteristics and course of functional capacity and health status. Furthermore, we investigated the outcomes of the Clinical COPD Questionnaire (CCQ) and related (change in) health status to lung function, degree of dyspnea and (change in) functional capacity. We concluded that post-acute GR is feasible and likely to offer substantial improvements in health status and functional capacity and that health status measured by the CCQ is sensitive to change this specific group of patients.



Objective: To determine the (cost) effectiveness of the GR-COPD program in patients with severe COPD admitted to the hospital with an acute exacerbation.



Study design: A longitudinal prospective multicentre cohort study



Study population: Patients diagnosed with severe COPD and admitted to the hospital with an acute exacerbation. Furthermore, patients need to have an indication for rehabilitation based on a set of standard major and minor criteria. Patient who suffer from conditions interfering with rehabilitation, such as: end-stage disease, a major psychiatric or cognitive disease or insufficient mastery of Dutch language, are excluded from participation.

Setting: This study is being conducted on the pulmonary department of two local hospitals in the Netherlands.



Intervention: The intervention group receives the GR-COPD program. The GR-COPD program consists of a multidisciplinary inpatient rehabilitation program and contains several modules concerning different aspects of rehabilitation: optimizing pulmonary medication use, compliance and inhalation techniques, physiotherapy (endurance, strength and inspiratory muscle training), occupational therapy, support of smoking cessation, nutritional analysis and advise, analysis of speech and breathing techniques, psychosocial intervention, education and peer support contact.

Main study parameters/endpoints:

Effect evaluation:

-Improvement in health and functional status as measured by the CCQ and the 6MWT.

-Reduction of the number of COPD exacerbations and number of hospital admissions and in-hospital-days as a result of COPD exacerbations.

Process evaluation: Within the framework of the process evaluation, fidelity; completeness; exposure; satisfaction; reach; recruitment and context will be evaluated by quantitative and qualitative analysis.



Economic evaluation: Cost analysis (from a healthcare perspective) and cost-utility analysis (comparing healthcare costs to Quality-Adjusted Life Years).

Statistical analysis

To balance potential confounders between patients in the intervention (GR-COPD) and the usual care group of this study, we will estimate the propensity score (PS). To estimate the PS we identified potential confounders based on subject matter knowledge and will include the following variables in the PS: age, sex, marital status, lung-function (FEV1%pred), short-term oxygen therapy (STOT), exacerbation-frequency (Ex-freq) in year before admission, co-morbidity (CCI-score), smoking status, functional status (BI), nutritional status (BMI, FFMi), psychosocial functioning (HADS) and hospital location. All variables that are included in the PS are measured before treatment initiation (Indication-phase of the study). We then analysed distribution of all variables included in the PS within the dataset of the first 47 included patients. We will then estimate the PS (probability of receiving rehabilitation) for all individuals included in the dataset using a logistic model that includes 27 variables. Prior to data-analysis, continuous variables will be modelled in categorical variables when clinically relevant according to literature and when possible (not leading to instability), and when relation is not linear. We will consider the following clinically plausible interaction: sex vs marital status. In the third step the PS model will be evaluated using the standardized mean difference (SMD) to assess balance in potential confounders between the intervention and control groups with similar PS values. Distribution of the PS between treated and untreated groups will be examined by plotting histograms to assess extend of overlap. PS weighting technique will be used to estimate the treatment effect, as measured by the delta-CCQ. We will consider stratification methods as well. Primary analysis: intervention versus control group. Secondary analysis: Intervention versus several subgroups in control group; GR-general; Home-based-therapy; no therapy. Subgroup-analysis considering de two locations will not be performed because this was entered into the PS.

Geriatric rehabilitation in patients with severe COPD, admitted to the hospital with an acute exacerbation, will improve health status and decrease the exacerbation frequency and hospital admissions in comparison to patients who do not receive this rehabilitation program.

- Baseline measurements (T0): first week of admission to the hospital

- Follow up 1: 3 months after T0

- Follow up 2: 6 months after T0

- Follow up 3: 9 months after T0

- Follow up 4: 12 months after T0

The control group receives care as usual. The intervention group receives the GR-COPD program. The GR-COPD intervention consists of a multidisciplinary inpatient rehabilitation program and contains several modules concerning different aspects of rehabilitation: optimizing pulmonary medication use, compliance and inhalation techniques, physiotherapy (endurance, strength and inspiratory muscle training), occupational therapy, support of smoking cessation, nutritional analysis and advise, analysis of speech and breathing techniques, psychosocial intervention, education and peer support contact.