The aim of this study is to investigate whether a mobile telemonitoring guided CR (mCR) as alternative for a regular CR programme is an effective means to increase participation and adherence of elderly in a CR programme, and results in better long…
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in peak oxygen uptake (VO2peak) between the end of CR programme (T1)
and baseline (T0)
Secondary outcome
Physical fitness:
- Difference in peak oxygen uptake obtained from an incremental exercise test
(T2-T0)
- Difference in peak oxygen uptake obtained from an incremental exercise test
(T2-T1)
Traditional risk factors:
- Changes in lipid profile (T1-T0, T2-T0)
- Changes in HbA1C (T1-T0, T2-T0)
- Changes in renal function (T1-T0, T2-T0)
- Changes in lean body mass (T1-T0, T2-T0)
- Changes in blood pressure (T1-T0, T2-T0)
- Changes in smoking habit (T2-T0)
Major Adverse Cardiovascular Events (MACE):
- The occurrence of events (cardiovascular (CV) mortality, all-cause mortality,
near sudden cardiac death, ACS, CV intervention/surgery, CV hospital admission,
CV emergency visits) as composite endpoint (T1-T2) are registered and collected
by monthly telephone calls.
General health:
- Difference in depression score assessed by: PHQ-9 questionnaire (T1-T0,
T2-T0)
- Difference in anxiety score assessed by GAD-7 questionnaire (T1-T0, T2-T0) -
Quality of Life: SF-36, difference in Physical Component Summary Score and
Mental Component Summary Score (T1-T0, T2-T0)
- Care utilisation as composite endpoint of: (number of) admissions, emergency
visits and cardiac interventions (PCI, CABG) (T1-T2)
- Costs of care utilisation based on activities (clinical admission days,
emergency and outpatient clinic visits, GP visits for cardiac (related)
complaints or issues, radiology/cardiophysiology/nuclear and laboratory tests,
and cardiac interventions) registered at T0, T1 and T2 and collected by monthly
telephone calls with the participants between T1 and T2
Adherence:
- Number of drop-out or completed CR throughout study period.
Compliance:
- Compliance to usage of the smartphone (percentage of fulfilling the planned
exercise sessions with mCR for at least half an hour at 5 five days per week)
in the intervention group is determined for the period between baseline and 6
months.
Background summary
Cardiovascular diseases (CVDs), such as coronary heart disease and stroke, are
one of the four main non-communicable diseases in the world causing over 4
million deaths in Europe each year. Not only mortality rates are high,
morbidity of CVD patients is becoming an increasingly important problem.
Through enormous improvements in high-technology diagnostic and therapeutic
procedures the survival rates from CVD in (Western) Europe have increased
substantially. Yet, the recurrence rate of CVD events and consumption of care
resulting from CVD, or associated co-morbidities are high and patient numbers
are expected to rise the next decades due to an ageing population. Literature
shows that comprehensive cardiac rehabilitation (CR) is highly effective.
However,knowledge on the effectiveness of individual CR components and their
appropriateness for specific patient groups (young versus elderly) is limited.
The current approach for CR is often less appropriate for the elderly, as a
result of which effectiveness, compliance, participation levels and
cost-utility of CR programmes in this group is hampered. Home-based CR seems to
be equally effective as centre-based CR and has the potential to increase the
participation rate. In combination with novel e-Health applications (where
guidance from distance is enabled), home-based care could overcome barriers to
access to CR and therefore be a useful tool for increasing participation.
Furthermore it seems that telehealth interventions are effective in improving
self-management skills and provide effective risk factor reduction and
secondary prevention. However, this is only shown on the short term, long term
effectiveness of telehealth interventions is still not known.
Study objective
The aim of this study is to investigate whether a mobile telemonitoring guided
CR (mCR) as alternative for a regular CR programme is an effective means to
increase participation and adherence of elderly in a CR programme, and results
in better long term effects than in patients who do not follow the mCR
programme. In addition the cost effectiveness of the mCR programme will be
analysed.
Study design
Randomised controlled trial
Intervention
Patients aged 65 years and older, who are candidate for CR, but nut opting for
regular CR are randomised in two study arms: the mCR programme for 6 months or
no mCR programme. The mCR programme involves a home-based programme for 6
months in which patients are supplied with a smartphone/application with a data
subscription from MobiHealth. Through this application patients are able to
measure and register physical activity, heart frequency and intensity (BORG
scale) and can monitor progress. Patients are instructed to perform a moderate
exercise 5 days per week for at least half an hour. A care professional
(typically a CR nurse) also has access to a portal to monitor progress of
different patients, advice on rehabilitation approach and stimulate compliance
telephone calls. During the first month patients receive weekly individual
coaching and feedback on their results by telephone, in the second month this
will be once per two weeks, whereas one monthly call will be held in the last
four months (month 3 until 6) of the mobile telemonitoring period. In the
second period without mobile telemonitoring (month 7 until 12) patients will
receive no coaching or feedback by phone. Patients participating in the control
group with no mCR programme receive no advice or coaching throughout the study
period.
Study burden and risks
Noninvasive cardiac testing procedures in this study are not related to any
potential risk for the participant. Maximal ergometer tests will be performed
at the hospital under supervision of highly qualified personnel. A possible
complication of venipuncture is a hematoma, which is induced in ~5% of all
cases. To prevent complications, an experienced professional will perform the
blood withdrawal and sufficient pressure will be provided after withdrawal of
the needle. As patients are carefully instructed beforehand and individually
coached by telephone on their physical progress during the first 6 months of
the study we expect no potential risk for them to exercise in their home
environment.
Dokter van Heesweg 2
Zwolle 8025AB
NL
Dokter van Heesweg 2
Zwolle 8025AB
NL
Listed location countries
Age
Inclusion criteria
- Patients of 65 years or older who are a candidate for CR and non-voluntary to
participate in the regular CR programme
- Signed written informed consent
- One of the following criteria:
o Patients with an acute coronary syndrome, including myocardial infarction (MI) and/or revascularisation
within 3 months prior to the start of the CR programme
o Patients that underwent a percutaneous coronary intervention (PCI) within 3
months prior to the start of the CR programme
o Patients that received coronary artery bypass grafting (CABG) within 3 months
prior to the start of the CR programme
Exclusion criteria
- Contraindication to CR
- Mental impairment leading to inability to cooperate
- Severe impaired ability to exercise
- Signs of severe cardiac ischemia and/or a positive exercise testing on severe cardiac ischemia
- Insufficient knowledge of the native language
- No access, availability or insufficient knowledge of a computer with internet
- Implanted cardiac device (pacemaker, ICD)
Design
Recruitment
Medical products/devices used
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 | NL52862.075.15 |