No registrations found.
ID
Source
Brief title
Health condition
COPD, chronic heart failure
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is to investigate whether TM in patients with combined HF and COPD results in improved quality of life (EQ-5D), as compared to usual care.
Secondary outcome
1. To investigate whether TM in patients with combined HF and COPD results in improved HRQoL (MLHFQ, SGRQ).
2. To investigate whether TM results in improved levels of self-management as compared to usual care (PAM13).
3. To investigate patient satisfaction with TM compared to usual care (CQi)
4. To investigate whether patients are compliant to the TM program.
5. To assess health-care costs of TM compared with usual care.
Background summary
Chronic heart failure (CHF) and chronic obstructive pulmonary disease (COPD) often co-exist and are associated with high morbidity and mortality. Telemonitoring (TM) can improve early detection of deterioration and prevent re-admissions. Although telemonitoring is already implemented in several Dutch hospitals for CHF or COPD, care pathways for these conditions are usually separated. Because there is a call for a more holistic approach, we propose a combined TM approach for both diseases in an integrated care pathway.
Study objective
Telemonitoring in patients with chronic heart failure (CHD) and chronic obstructive pulmonary disease (COPD) might result in improvement of quality of life as compared to usual care.
Study design
We conduct a quasi-experimental time-series study in which the main endpoint is assessed every month between during 2.5 years.
Intervention
During a period of 2 years patients receive a personalized set of sensors for monitoring relevant vital signs (e.g. blood pressure, weight, oxygen saturation, energy expenditure and/or temperature). Sensor data in combination with short questionnaires on clinical status will be uploaded on a digital platform on a regular basis. Data are reviewed in the hospital by a specialized nurse who serves as the patients' case manager. If measurements exceed predefined limits, the cardiologist and pulmonologist are consulted in a multidisciplinary setting on the same day to determine the treatment strategy.
C. Herkert
De Run 4600
Veldhoven 5504 DB
The Netherlands
+31 40-888 8200
cyrille.herkert@mmc.nl
C. Herkert
De Run 4600
Veldhoven 5504 DB
The Netherlands
+31 40-888 8200
cyrille.herkert@mmc.nl
Inclusion criteria
1. Patients diagnosed with both CHF (HFrEF, HFpEF or HFmrEF) and COPD regardless of aetiology.
2. At least one hospital admission during the last year (due to CHF/COPD).
3. Age =/> 16 year.
4. Able to speak and read the Dutch language.
5. Life expectancy > 2.5 years.
6. Sufficient digital skills (or caregiver).
Exclusion criteria
1. Patients that do not have an internet connection.
2. Patients with psychological disorders preventing participation.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6741 |
| NTR-old | NTR6919 |
| Other | METC Máxima Medisch Centrum // CCMO : W18.002 // NL64413.015.17 |