Skip to content

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

Geriatric Rehabilitation in patients with severe COPD

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27813
Enrollment
180
Registered
2017-01-25
Start date
2015-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Geriatric Rehabilitation, COPD, health status, post-acute pulmonary rehabilitation, functional status, cost-effectiveness

Interventions

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 se

Sponsors

-
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Main inclusion criteria: - Diagnosed with severe COPD - Admitted to the hospital with an acute exacerbation - Indication for rehabilitation: this is based on the presence of 2 major, or 1 major and 2 minor criteria. Major criteria: 1. Decline of functional status (ADL, iADL) 2. Health status is severely impaired, as measured by the Clinical COPD Questionnaire (CCQ), score > 2,0 3. Frequent exacerbations; ¡Ý 2 in the last 6 months (excluding the present exacerbation) Minor criteria: 1. Hypoxaemia (excluding pre-existent long-term oxygen treatment (LTOT)) 2. Impaired nutritional status: body mass index (BMI)7 on either subscale

Exclusion criteria

Exclusion criteria: The patient has a condition interfering with rehabilitation, such as: 1. End-stage disease 2. A major psychiatric or cognitive disease 3. Insufficient mastery of Dutch language

Design outcomes

Primary

MeasureTime frame
1.Health status as measured by the Clinical COPD Questionnaire (CCQ); delta-CCQ during follow-up , compared between GR-COPD intervention group and usual care. 2. Functional status as measured by the 6-minute walking test (6MWT); delta-6MWT during follow-up, compared between GR-COPD intervention group and usual care.

Secondary

MeasureTime frame
A. The following parameters will be compared between GR-COPD intervention and usual care: -Number of COPD exacerbations and number of hospital admissions and in-hospital-days as a result of COPD exacerbations. -Mortality rate. B. Process evaluation. In accordance with the theory of Saunders and using a mixed-method approach (self-administered questionnaire and qualitative group interviews), fidelity; completeness; exposure; satisfaction; reach; recruitment and context will be evaluated as part of the process evaluation. C. Economic evaluation. The economic evaluation consists of a cost analysis and a cost-utility analysis, both with a twelve-month time horizon after inclusion (during follow-up). Costs will be measured from a healthcare perspective. In the cost-utility analysis, the difference in healthcare costs between the strategies will be compared to the difference in Quality-Adjusted Life Years (QALYs, calculated using the Dutch EQ-5D tariff and the visual analogue scale for health). Estimated healthcare costs will include the costs of the GR-COPD intervention (estimated from the study registration) and other healthcare utilization (estimated using quarterly questionnaires filled out by the patients). Other healthcare utilization will include general practitioners, home care, hospitalization, and residential care. A cost-price analysis will be performed for the GR-COPD; other healthcare will be valued using standard prices.

Contacts

Public ContactLeonoor van Dam van Isselt

LUMC

E.F.vanDamvanIsselt@lumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)