Renewing Health RCT in Central Greece for the Evaluation of Short-term Telehealth Follow up After Hospital Discharge for COPD Exacerbation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 155
- Locations
- 1
- Primary Endpoint
- Number of hospital readmissions
Study Overview
Brief Summary
The purpose of this study is to evaluate whether the introduction of a short-term telemonitoring program for chronic obstructive pulmonary disease (COPD) patients discharged from the hospital after disease exacerbation produces benefits in terms of a reduction in hospital readmissions and health related quality of life. In addition the trials evaluate the economical and organisational impact of the services and examine their acceptability by patients and health professionals.
Detailed Description
The purpose of this study is to the evaluate the use of a close phone-based tele-monitoring platform will reflected by less hospital re-admissions, will change their generic and disease specific quality of life compared with usual care. Following this; it is also hypothesized that this will also lead to less patients' deaths. In addition the patients' satisfaction using the telemedicine service will be studied. A Cost-Effective Analysis will evaluate the tele-health service compared with the usual care from the health and social perspective.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Exacerbation of COPD according to the GOLD guidelines
- •Age > 40 years
- •Capability to use the devices provided
- •Willing to participate
Exclusion Criteria
- •included in previous COPD monitoring study
Arms & Interventions
Usual care
Patients in the control group receive usual care and visit the outpatient department at 4 and at 12 weeks after discharge when pulse rate, oxygen saturation and spirometry is performed. In the case of clinical deterioration during the study, the patients contact as usual their general practitioner. Usual care of COPD patients consists of regular visits to the specialist or primary care clinics every time a medication change is made or a medical examination is needed
Telemonitoring
Intervention: Telemonitoring (Procedure)
Outcomes
Primary Outcomes
Number of hospital readmissions
Time Frame: 3 months period
Number of hospital readmissions after the hospital discharged of the patient after a COPD exacerbation
Secondary Outcomes
- Hospital anxiety and depression scale HADS(3 months - at the entry point of the intervention and the end.)
- Health status, measured with the St. George's Respiratory Questionnaire SGRQ(3 months - at the entry point of the intervention and the end.)
- Lung condition as measured by FEV1(1 month after the hospital discharge.)
- Mortality(3 months period)
- Patients' Acceptance-Satisfaction measured by the WSD Questionnaire(at the 3rd month of the tele-monitoring)
- Health related quality of life of the patients as measured by the SF-36 version 2 questionnaire(3 months - at the entry point of the intervention and the end.)
Investigators
Konstantinos Gourgoulianis
Professor, Director of the Pulmonary Department, University Hospital of Larisa
Regional Health Authority of Sterea & Thessaly