The SO-HIP study,
Effectiveness of sensor monitoring in an occupational therapy rehabilitation program for older persons after hip fracture: design of a three-arm stepped wedge cluster randomized trial

After hip fracture, 20-90% of older persons experience new disabilities in
activities of daily living (ADL) that affect their ability to remain living
independently at home. Fear of falling hinders older persons to perform ADLs
needed for good recovery. Increasing self-efficacy beliefs can reduce fear of
falling and can help increase physical activity needed to recover. By goal
setting, better insight in the ADLs of older persons performance and recovery
after hip fracture might be enhanced. New technologies such as sensor
monitoring can be used as a coaching tool. Currently it is unclear how
effective sensor monitoring embedded in an occupational therapist (OT)
rehabilitation program is in the recovery of ADLs compared to coaching by an OT
alone or care as usual

The primary objective is to study the effect of sensor monitoring embedded in
an OT rehabilitation program for older persons after hip fracture on recovery
of daily functioning, 6 months after the start of rehabilitation, as compared
to coaching by an OT without sensor monitoring and care as usual. The secondary
objectives are:
-to investigate the effect of the intervention on physical activities and
activities of daily living, 1, 3 and 6 months after the start of the
rehabilitation.
-to investigate the effect of the intervention on sense of safety, fear of
falling and health-related quality of life, 1, 3 and 6 months after the start
of the rehabilitation.
-to investigate the effect of the intervention on the use of healthcare
resources 1, 3 and 6 months after the start of the rehabilitation.

A sequential double hybrid stepped wedge cluster randomized trial with the
nursing homes (clusters) as the units of randomization. All clusters will start
with the usual care at the beginning of the study. At each time point (after
three months), a cluster crosses over from usual care to coaching by an OT and
at the next time point to sensor monitoring embedded in an OT coaching-program.
The study will be conducted in two separate phases: a feasibility study and a
main study.
Randomization: Nursing homes will be randomized via web-based central
randomization, and determines the sequence in which a nursing home will start
the three interventions. Each sequence contains all three interventions, albeit
with different durations.

All patients receive multidisciplinary rehabilitation as care as usual. On top
of the usual care, patients in the first intervention group receive an OT
rehabilitation program, using cognitive behavioral treatment (CBT) principles
concerning falls consisting of five steps: 1) to educate being physical active
and to stimulate physical activity and exercises, 2) to ascertain the amount of
movement and physical activity during the day and give feedback 3) to set
realistic goals for the performance of daily activities 4) to plan these
activities and 5) to evaluate progress. The coaching consists of a weekly
session with an occupational therapist during nursing home stay followed by 4
home visits and 4 telephone consultations. In the sensor monitoring group,
sensor monitoring is added to the OT coaching program. Patients receive a
sensor monitoring system consisting of (i) a wearable activity monitor during
the stay in the nursing home, (ii) a wireless sensor monitoring system at home
and a (iii) a web-based feedback application. These components will be embedded
in the coaching program. This coaching approach too, consists of a weekly
session with an occupational therapist during nursing home stay followed by 4
home visits and 4 telephone consultations
Usual care: Usual care consists of a multidisciplinary rehabilitation program
as per nursing home, by a multidisciplinary rehabilitation team. The focus of
the rehabilitation will be PT. If needed, some of the patients receive
rehabilitation at home or at an outside rehabilitation ward of the nursing
home. The amount of OT given by the nursing homes will be different varying
from none to a few sessions.
Follow up: Patients are followed-up until six months after the start of
geriatric rehabilitation in a nursing home

In the sensor monitoring group, sensor monitoring is added to the OT coaching
program. Patients receive a sensor monitoring system consisting of (i) a
wearable activity monitor during the stay in the nursing home, (ii) a wireless
sensor monitoring system at home and a (iii) a web-based feedback application.
This coaching approach too, consists of a weekly session with an occupational
therapist during nursing home stay followed by 4 home visits and 4 telephone
consultations.

There are four moments of measurements for all participants: at baseline,
before discharge nursing home to home and three and six months after start of
the rehabilitation in the nursing home.
The outcome measurements are non-invasive and the last two measurements will
take place at the patient*s home.
There are no foreseeable risks associated with the intervention or measurements
for the study.