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Telemonitoring in patients with chronic heart failure and COPD.


- candidate number28337
- NTR NumberNTR6919
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-dec-2017
- Secondary IDsW18.002 // NL64413.015.17 METC Máxima Medisch Centrum // CCMO
- Public TitleTelemonitoring in patients with chronic heart failure and COPD.
- Scientific TitleQuality assessment of an integrated care pathway using telemonitoring in patients with chronic heart failure and COPD
- ACRONYMIN-TOuCH
- hypothesisTelemonitoring 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.
- Healt Condition(s) or Problem(s) studiedCOPD, Chronic Heart Failure
- Inclusion criteria1. 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 ¡Ý 18 year
4. Able to speak the Dutch language
5. Life expectancy > 1 year
6. Cognitively able to attend telemonitoring (or caregiver)
- Exclusion criteriaPatients that do not have internet connection.
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-feb-2018
- planned closingdate1-feb-2022
- Target number of participants110
- InterventionsDuring 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.
- Primary outcomeThe 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 outcome1. 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.
- TimepointsWe conduct a quasi-experimental time-series study in which the main endpoint is assessed every month between during 2.5 years.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD C. Herkert
- CONTACT for SCIENTIFIC QUERIESMD C. Herkert
- Sponsor/Initiator Maxima Medical Center, Veldhoven
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryChronic 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.
- Main changes (audit trail)
- RECORD11-dec-2017 - 8-jan-2018


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