Telemonitoring in COPD patients

Rationale:
The number of patients with Chronic Obstructive Pulmonary Disease (COPD) is growing
rapidly. COPD is associated with high mortality rates, high use of healthcare resources
and lower quality of life. The increasing prevalence of COPD and accompanying
increased workload leads to a substantial impact on the healthcare society worldwide.
Therefore, structural changes in the organization of healthcare are needed to
accommodate this patient population, with an important role for improving selfmanagement
for COPD patients using telemonitoring interventions. Telemonitoring may
support activation for self-management while enabling quicker treatment in the early
phase of patient deterioration. In addition, it is expected to reduce exacerbation
frequency, number of hospital readmissions and costs.
The aim of this study is therefore to test the hypothesis that telemonitoring with telecare
in COPD-patients will improve self-management. In addition, it is hypothesized that
telemonitoring with telecare will reduce disease burden and healthcare resource usage.
Objective: The primary aim of this study is to test the hypothesis that telemonitoring with
telecare in COPD-patients will improve self-management, as measured with the 13-item
Patient Activation Measure (PAM-13). Furthermore, we hypothesize that telemonitoring
with telecare will reduce disease burden and healthcare resource usage.
Study design: A pragmatic unblinded randomized controlled trial with 12-months follow
up. The control group receives care as usual. The intervention group receives usual care
in addition to the telemonitoring intervention.
Study population: 178 adult patients with COPD GOLD stage B and D will be randomly
assigned to the intervention or control group at the Deventer Hospital
Intervention ((if applicable): an integrated home telemonitoring solution that consists of
at home measurements of the clinical COPD questionnaire (CCQ), saturation, pulse rate
and weight via a specially designed telemonitoring application on a patient’s phone or
tablet. Video consultations by nursing staff are initiated if patient specific alerts are
generated.
Main study parameters/endpoints: The primary endpoint is self-management as
measured with the Patient Activation Measure (PAM-13) at baseline, 3, 6 and 12
months. Secondary outcomes are quality of life (EQ-5D-5L), number of exacerbations,
number of hospital admissions, number of ED visits and patient satisfaction.
Nature and extent of the burden and risks associated with participation, benefit
and group relatedness: All patients, regardless of randomization will receive standard
of care for COPD management. In addition, patients in both the intervention and control
group will fill in questionnaires on patient-self management (PAM-13) and quality of life
(EQ-5D-5L) at baseline, 3, 6 and 12 months. It is expected that the burden to fill in both
these questionnaires is extremely low, since short questionnaires are selected.
Telemonitoring of COPD patients in the intervention group could be perceived as an
additional patient safety net since patients in the intervention group receive
telemonitoring care in addition to usual care. Therefore, there are no conceivable risks to
taking part in this study.

We hypothesize that telemonitoring with telecare in COPD-patients will improve selfmanagement.
In addition, it is hypothesized that telemonitoring with telecare will reduce
disease burden and healthcare resource usage.

The main study parameter is self-management as measured with the Patient Activation
Measure (PAM-13) at baseline, 3, 6 and 12 months.

This present study is an unblinded prospective randomized controlled trial with
12-months follow up in a Teaching Hospital (Deventer Ziekenhuis). The control group
receives care as usual. The intervention group receives the telemonitoring intervention
in addition to usual care. Since telemonitoring is not part of the current care pathway, we
choose to provide usual care to the intervention group as well.