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Tele-rehabilitation Intervention for People Post Hip Fracture - Randomized Controlled Trial (RCT)

Effectiveness of a Tele-rehabilitation Intervention to Improve Performance and Reduce Morbidity for People Post Hip Fracture - Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03376750
Enrollment
90
Registered
2017-12-18
Start date
2017-01-01
Completion date
2019-03-31
Last updated
2017-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fractures

Keywords

telerehabilitation, occupational therapy, RCT, participation, quality of life, intervention, older adults

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

Interventions

BEHAVIORALCO - OP

CO-OP is a top-down, task-oriented, client-centered approach that uses an iterative process of dynamic performance analysis and guided discovery to enable individuals to identify strategies that will improve performance

Sponsors

Hebrew University of Jerusalem
CollaboratorOTHER
Israel National Institute for Health Policy and Health Services Research
CollaboratorOTHER_GOV
Herzog Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

three-arm randomized control trail (RCT) including pre/post intervention and follow-up

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline at post intervention in The Canadian Occupational Performance Measure (COPM)Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 monthsThe COPM will be used for measuring performance and satisfaction with personally identified participation goals. Participants are asked to identify goals and then rate their performance and satisfaction with current status on a scale from 1 to 10, where 10 indicates optimal performance or satisfaction

Secondary

MeasureTime frameDescription
Functional Independence Measure (FIM)Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 monthsThe aim of the FIM is to monitor the recovery of functional ability by people undergoing rehabilitation. The FIM is comprised of 18 parameters, each rated on a scale of 1-7 (range = 18-126) according to the degree of assistance required to perform a specific activity
The Geriatric Depression Scale (GDS)Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 monthsThe scale consists of 15 items; each item has two possible answers (yes or no). The highest possible score is 15, which indicates the most severe depressive state.
12-item MOS Short-Form Health Status Survey, Hebrew versionBaseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 monthsThis generic HR-QoL instrument focuses on functional status. The questionnaire includes 12 items taken directly from the SF-36\[73\] which are used to calculate the Physical and Mental Component Summary. The first question measured by the SF-12 is an acceptable self-rated measure for general health
The Zarit Caregiver Burden InterviewBaseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 monthsThe ZBI includes 22 statements recorded in a 0-4 Likert scale (total score range 0 to 88, where higher scores mean higher burden), which rates the subjective component of burden
Qualitative interviewpost intervention, 10 weeks (T1)Semi-structured interviews will be conducted post intervention with the patients and their caregivers to identify barriers and facilitators regarding the intervention

Countries

Israel

Contacts

Primary ContactYafit Gilboa, OTphD
yafitgilboa@yahoo.com+972523362230
Backup ContactTalia Maeir, BOT
taliabengigi@gmail.com+972547866338

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026