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

NCT03376750 | Unknown

• 1 other identifier: HerzogH RCT
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Hip Fractures

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline at post intervention in The Canadian Occupational Performance Measure (COPM)

  The 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

  Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months

Secondary Outcomes (5)

• 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 months

• 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 months

• 12-item MOS Short-Form Health Status Survey, Hebrew version

  Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months

• The Zarit Caregiver Burden Interview

  Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months

• Qualitative interview

  post intervention, 10 weeks (T1)

Study Arms (3)

CO - OP via telerehabilitation + standard care

EXPERIMENTAL

10 CO-OP videoconferencing sessions from an occupational therapist . 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.

Behavioral: CO - OP

CO - OP via face to face + standard care

EXPERIMENTAL

10 CO - OP face to face sessions from an occupational therapist. 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.

Behavioral: CO - OP

control group - standard care

NO INTERVENTION

standard care as given from public health service

Interventions

CO - OP BEHAVIORAL

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

Also known as: Cognitive Orientation to Occupational Performance

CO - OP via face to face + standard care; CO - OP via telerehabilitation + standard care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Herzog Hospital: lead
• Hebrew University of Jerusalem: collaborator
• Israel National Institute for Health Policy and Health Services Research: collaborator

Study Sites (1)

Herzog Hospital

Jerusalem, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 31109289 DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Yafit Gilboa, OTphD

  School of Occupational Therapy, Faculty of Medicine Hadassah and the Hebrew University of Jerusalem

  STUDY DIRECTOR

Central Study Contacts

Yafit Gilboa, OTphD

CONTACT

+972523362230; yafitgilboa@yahoo.com

Talia Maeir, BOT

CONTACT

+972547866338; taliabengigi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

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

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 18, 2017
• Study Start: January 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: March 31, 2019
• Last Updated: December 18, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)