Clinical trial NCT03376750: Tele-rehabilitation Intervention for People Post Hip Fracture - Randomized Controlled Trial (RCT)
Official title: Effectiveness of a Tele-rehabilitation Intervention to Improve Performance and Reduce Morbidity for People Post Hip Fracture - Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fractures
Keywords: telerehabilitation
occupational therapy
RCT
participation
quality of life
intervention
older adults
Lead sponsor: Herzog Hospital
Sponsor class: OTHER
Collaborators: name: Hebrew University of Jerusalem
name: Israel National Institute for Health Policy and Health Services Research
First posted: 2017-12-18
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: three-arm randomized control trail (RCT) including pre/post intervention and follow-up
Primary purpose: TREATMENT

Brief summary: Most surviving hip-fracture patients experience reduced mobility and lose their functional ability, which increases the risk of complications and rehospitalization. Post-discharge transitional programs to reduce readmissions have shown some success. Telerehabilitation refers to the use of technologies to provide rehabilitation services to people in their homes. Considering the need for long-term follow-up care for people with hip fracture, in-home telerehabilitation could increase independence, decrease hospital stays and reduce the burden for caregivers.

The purpose of this three armed randomized controlled trial is to investigate the effectiveness of an intervention program based on telerehabilitation on ADL, QOL, depression and burden on caregivers compared to face-to-face home visits and usual care of community-dwelling older adults after hip fracture.

90 older people with hip fractures will be randomly assigned to a telerehabilitation group (N=30), face-to-face visits (N=30) and a control group.

The aim of the intervention is to improve the transition from rehabilitation units to community dwelling. It will include 10 videoconferencing/ face-to-face sessions from an occupational therapist in the presence of the primary caregiver. Each session will be utilized to guide the participants to achieve their self-identified goals, focusing on problem-solving for daily life situations and on the ability to implement the discussed strategies for a variety of activities


Eligibility criteria: Inclusion Criteria:

Older adults (age ≥60 years) post hip fracture - discharged from the inpatient rehabilitation unit of Herzog Hospital, Jerusalem, between January 2017 and December 2017.

Discharge from rehabilitation to a non-institutionalized setting. broadband or Wi-Fi in their home and must be able to operate an iPad independently.

FIM\>90 at discharge. Has a designated caregiver (a close friend, family member, or support worker) aged over 18, and a Hebrew, English or Arabic speaker, who will agree to cooperate in the research

Exclusion Criteria:

Aphasia. cognitive impairment (Montreal Cognitive Assessment scores : MOCA\<19 or MMSE\<21).

degenerative neurological diagnoses. current major depressive or psychotic disorder. other acute or chronic health condition that will influence their ability to participate in the study.

Primary outcomes:
measure: Change from baseline at post intervention in The Canadian Occupational Performance Measure (COPM)
timeFrame: Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months
Secondary outcomes:
measure: Functional Independence Measure (FIM)
timeFrame: Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months
measure: The Geriatric Depression Scale (GDS)
timeFrame: Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months
measure: 12-item MOS Short-Form Health Status Survey, Hebrew version
timeFrame: Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months
measure: The Zarit Caregiver Burden Interview
timeFrame: Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months
measure: Qualitative interview
timeFrame: post intervention, 10 weeks (T1)
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Herzog Hospital
Study officials:
affiliation: School of Occupational Therapy, Faculty of Medicine Hadassah and the Hebrew University of Jerusalem
name: Yafit Gilboa, OTphD
role: STUDY_DIRECTOR
References:
citation: Gilboa Y, Maeir T, Karni S, Eisenberg ME, Liebergall M, Schwartz I, Kaufman Y. Effectiveness of a tele-rehabilitation intervention to improve performance and reduce morbidity for people post hip fracture - study protocol for a randomized controlled trial. BMC Geriatr. 2019 May 20;19(1):135. doi: 10.1186/s12877-019-1141-z.