Primary: to investigate the effectiveness of using Hospital Fit as part of the physiotherapy treatment on average time spent walking per day in patients hospitalised at the Medical Oncology or Cardiology Departments of the Maastricht University…
ID
Source
Brief title
Condition
- Other condition
- Cardiac disorders, signs and symptoms NEC
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Health condition
General cardiac disorders and malign neoplasms are addressed
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome parameter: average time spent walking per day (min).
Secondary outcome
Secondary outcome parameters: average time spent standing and lying/sitting per
day (min.), average number of transitions from lying/sitting to
standing/walking per day, and mILAS score per day. Outcome parameters process
evaluation: participation; representation; perceived efficacy; use of app; use
of different functionalities; barriers and facilitators to Hospital Fit use;
and expected maintenance.
Background summary
Physical inactivity is a major, underrecognised problem in patients during
their hospital stay. Patients spend between 87 and 100% of their time lying or
sitting. This physical inactivity has been associated with adverse outcomes
such as functional decline, increased length of hospital stay and mortality.
Digital health tools could be valuable to prevent negative effects of
inactivity. Hospital Fit is a promising app-based intervention to stimulate
physical activity by 1) continuous physical activity monitoring, 2)
goalsetting, 3) providing patients insight in their functional recovery, 4)
providing patients tailored exercise programs, 5) informing patients about
benefits of physical activity, 6) reminding patients to use Hospital Fit and 7)
linking the data to the electronic medical record, making it available for
other healthcare professionals.
Study objective
Primary: to investigate the effectiveness of using Hospital Fit as part of the
physiotherapy treatment on average time spent walking per day in patients
hospitalised at the Medical Oncology or Cardiology Departments of the
Maastricht University Medical Center (MUMC+) and Radboud University Medical
Center (Radboudumc) compared to patients who received physiotherapy before
implementation of Hospital Fit. Secondary: 1) to investigate the effectiveness
of using Hospital Fit as part of the physiotherapy treatment on average time
spent standing per day, average time spent lying/sitting per day, average
number of transitions per day and the Modified Iowa Level of Assistance scale
(mILAS) scores in hospitalised patients; and 2) to investigate the reach,
efficacy, adoption, and implementation of using Hospital Fit as part of the
physiotherapy treatment from the perspective of both patients and healthcare
professionals.
Study design
A prospective, multi-centre, stepped-wedge cluster-randomised trial (SW-CRT)
will be performed to investigate the effectiveness of Hospital Fit.
Additionally, a process evaluation will be performed using semi-structured
interviews and questionnaires in patients and focus-group interviews in
healthcare professionals. Data will be collected between April 2022 and
November 2022.
The data will be collected on patient and healthcare professional level
in four clusters: two academic centres in the Netherlands (MUMC+ and
Radboudumc) and two departments per setting (Medical Oncology and Cardiology
Departments). Hospital Fit will be implemented in a stepped-wedge manner. All
clusters will begin with a non-intervention phase during which included
patients will receive usual care physiotherapy treatment without using Hospital
Fit. During the non-intervention phase, included patients will receive usual
care physiotherapy and will additionally wear an accelerometer to measure their
physical activity behaviour for a maximum of nine days. However, the patient
and healthcare professionals do not gain insight in the patients* physical
activity data. The non-intervention phase lasts two to five months, depending
on the cluster. After two months, Hospital Fit will be implemented as part of
the physiotherapy treatment in the first cluster. During the one-month
implementation phase, no patients will be included in the study in this
cluster. The goal of the implementation phase is to instruct physiotherapists,
nurses and physician(s) assistant(s) about the use of Hospital Fit. After the
implementation phase, the cluster will continue with an intervention phase
during which included patients will use Hospital Fit as part of the
physiotherapy treatment. They will wear an accelerometer to measure their
physical activity behaviour for a maximum of nine days, but both the patient
and the treatment team will be able to view the physical activity data. Every
month, a new cluster will transition from the non-intervention phase to the
implementation- and subsequently intervention phase until all four clusters are
in the intervention phase. Depending on the cluster, the intervention phase
will last two to five months. The order in which the four participating
clusters - MUMC+ Medical Oncology Department, MUMC+ Cardiology Department,
Radboudumc Medical Oncology Department, and Radboudumc Cardiology Department -
will transition from the non-intervention phase to the implementation phase
will be randomised by using a non-block randomised model in Castoredc.
The process evaluation will use the RE-AIM health promotion evaluation
framework to assess seven constructs of the intervention: participation;
representation; perceived efficacy; use of Hospital Fit; use of the different
functionalities of Hospital Fit; barriers and facilitators Hospital Fit use;
and expected maintenance. Qualitative data will be collected in the
intervention phase using semi-structured interviews in patients, and focus
group interviews in healthcare professionals. Quantitative data will be
collected in the intervention phase using questionnaires in patients. In the
questionnaires, patients in the intervention phase are asked to indicate
whether they have used Hospital Fit (the so called *users*) or whether they
have not used Hospital Fit (the so called *non-users*). This enables exploring
differences in patient characteristics between users and non-users in the
intervention phase.
Intervention
Physical activity will be measured in all patients with an accelerometer until
discharge with a maximum of nine days. The control group will receive usual
care physiotherapy (n=90), while the intervention group will use Hospital Fit
additionally (n=90).
Study burden and risks
The burden and risks on patients are minimal. The control group will receive
usual care physiotherapy and will wear an accelerometer. The intervention group
will use Hospital Fit additionally. Wearing a small accelerometer and using
Hospital Fit should not be a burden to patients. The only burden is the time it
takes to prepare subjects (install app, explain study). No invasive
interventions will take place. Anticipated benefits of Hospital Fit use include
improved physical activity, therewith reducing the negative effects associated
with low physical activity.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria patients (n=180):
In order to be eligible to participate in this study, a patient must meet all
the following criteria:
• Over 18 years old.
• Receiving physiotherapy at the Medical Oncology department or the Cardiology
department at the MUMC+ or Radboudumc.
• Enough understanding of the Dutch language.
• Owning a smartphone (operating system >= iOS13.0 or Android 8.0)
• Able to use a smartphone app
• Able to walk independently 2 weeks before admission, as scored on the
Functional Ambulation Categories (FAC >3)
Inclusion criteria healthcare professionals (n=24):
In order to be eligible to participate in the focus group interviews of the
proces-evaluation, a healthcare professional must meet all the following
criteria:
• Employed as physiotherapist, nurse or physician (assistant) at the Medical
Oncology Department or the Cardiology Department.
• Working at the MUMC+ or Radboudumc for at least one month.
Exclusion criteria
Exclusion criteria patients:
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• A contraindication to walking (as reported by a medical specialist in the
electronic medical record).
• A contraindication to wearing an activity monitor, fixed by a hypoallergenic
plaster at the upper leg (such as active bilateral upper leg infection, severe
oedema or bilateral transfemoral amputation).
• Admitted for cancers of the head and neck (i.e., cancer in the oral cavity,
throat (pharynx), voice box (larynx), paranasal sinuses and nasal cavity,
salivary glands).
• Admitted with cardiac arrhythmia and hemodynamic instability requiring
medication over 48 hours (i.e., beta blockers or noradrenaline) or invasive
treatment (i.e., pacemaker or defibrillator implementation).
• Mentally incapacitated subjects as reported by healthcare professionals in
the medical record. When any doubt arises, the patient will be excluded.
• Impaired cognition (delirium / dementia) as reported in the medical record by
a healthcare professional. When any doubt arises, the patient will be excluded.
• Unable to participate in the informed consent procedure or unable to provide
written informed consent.
• A life expectancy shorter than 3 months as mentioned by the medical
specialist in the medical record.
• Previous participation in this study.
Exclusion criteria healthcare professionals:
• No participation in care for patients at the Medical oncology Department or
Cardiology Department during the intervention phase (e.g., absence or research
employment).
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 |
|---|---|
| Other | - |
| CCMO | NL79684.068.21 |