To improve aftercare for patients with ABI receiving outpatient rehabilitation, aimed at promoting an active lifestyle to prevent persistent complaints after ABI and poor HR-QoL.
ID
Source
Brief title
Condition
- Structural brain disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The proportion of participants with ABI participating in the community buddy
program (target 60%) and feasibility (rating of satisfaction) of the program
will be calculated. In addition, it is investigated whether the program
promotes an active lifestyle by exploring objectively measured physical
activity, physical fitness and cognitive functioning of the intervention and
control group.
Secondary outcome
Secondary, it is examined whether the patient-reported outcomes (physical
activity, fatigue, anxiety, depression, cognitive complaints, coping, community
integration, HRQoL, physical fitness, health care use, return to work), which
are collected using validated questionnaires before and 3, 6 and 12 months
after discharge from outpatient rehabilitation, change over time.
Background summary
Many people with acquired brain injury (ABI) experience difficulties in
reintegration into their social life after discharge from the rehabilitation
center. It is also known that people with ABI do not meet the Dutch physical
activity guidelines; they have lower physical activity levels than healthy
people and they have difficulty maintaining their physical fitness level
reached during rehabilitation. An inactive lifestyle may lead to persistent
complaints, such as fatigue, anxiety or depression, and may result in a poor
health-related quality of life (HR-QoL).
Study objective
To improve aftercare for patients with ABI receiving outpatient rehabilitation,
aimed at promoting an active lifestyle to prevent persistent complaints after
ABI and poor HR-QoL.
Study design
Care improvement study using a prospective mono-center cohort with a pre-post
implementation study design. Implementation of an aftercare program that
strengthens the cooperation between rehabilitation center and local patient
support organisations in the community. The aftercare program integrates
standard outpatient rehabilitation and community services, including: 1)
standard brain education regarding long-term consequences of ABI, physical
activity guidelines, and patient support organizations in the area, including a
new, to be developped during the study, information leaflet; 2) new:
introduction of the patient to a buddy from a patient support organisation
during outpatient rehabilitation; 3) optional existing buddy support program
(max 8 hrs) in the community towards an active lifestyle after rehabilitation
discharge; 4) follow-up by the rehabilitation physician (standard care).
Study burden and risks
The implementation of the ABI-motion aftercare program involves integration of
standard outpatient rehabilitation and existing aftercare initiatives.
Participation in the ABI-motion program requires a certain time investment from
patients. The buddy program provides a maximum of 8 hours support towards an
active lifestyle. Participants with a contra-indication for moderate to
vigorous exercise will be guided towards light activities, such as walking.
Participation is voluntary. The total duration of the four patient measurements
will be 6 hours, in which patients are tested (3 visits) and (online)
questionnaires are completed (4 times), which may lead to temporary fatigue.
Regular breaks are provided. Optional focus groups will be organized to
evaluate the aftercare program, which will take 2 hours in total. Patients are
asked to wear a Geneactiv wristwatch and to keep an electronic diary during a
week along the baseline, 6 and 12 months visits to measure activity level over
time in the home environment. Burden of wearing small activity monitors in
daily life is low, based on experience in previous studies (e.g. MEC-2016-072).
We expect that patients will benefit from the ABI-motion aftercare program, if
they succeed in adopting an active lifestyle, in multiple aspects, including
reduction of persistent complaints after ABI and improvement of HRQoL, and that
the benefits of participation will outweigh the burden.
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
- Age at least 18 years
- Diagnosed with acquired brain injury (ABI)
- Follows an outpatient rehabilitation program for ABI in Rijndam
Rehabilitation
Exclusion criteria
- Life expectancy < 1 year
- Incapacitated persons.
Design
Recruitment
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 |
---|---|
ClinicalTrials.gov | NCT06058351 |
CCMO | NL85316.078.23 |