To investigate whether an integrated pathway using TM for patients with HF and COPD results in a delayed decline or improved quality of life. Secondary objectives are level of self-management, patient satisfaction, compliance to the program and cost…
ID
Source
Brief title
Condition
- Heart failures
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is to investigate whether TM in patients with combined CHF
and COPD results in a delayed decline or improved quality of life (EQ-5D), as
compared to usual care
Secondary outcome
Secondary endpoints are:
1. To investigate whether TM in patients with combined CHF and COPD results in
a delayed decline or 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 (PREM)
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 and
decreasing quality of life. 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
To investigate whether an integrated pathway using TM for patients with HF and
COPD results in a delayed decline or improved quality of life. Secondary
objectives are level of self-management, patient satisfaction, compliance to
the program and cost-effectiveness.
Study design
Quasi-experimental time series design.
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 a 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.
Study burden and risks
Participation in the TM program enables early detection of exacerbation of CHF
and COPD and is therefore assumed to be associated with a decreased risk at
hospitalization and increased quality of life. Therefore, TM is part of
national and international guidelines on CHF and COPD. Although TM is not
associated with additional risks, performing and uploading daily measurements
may be experienced as a burden for patients.
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
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 >= 18 year
4. Able to speak and read the Dutch language
5. Life expectancy > 2.5 years
6. Sufficient digital skills (or caregiver)
Exclusion criteria
The patient does not have internet connection
Having a psychological disorder preventing participation
Design
Recruitment
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 |
|---|---|
| CCMO | NL64413.015.17 |