NCT03300219

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 the pilot study is to examine the feasibility and acceptability of the research methods evaluating telerehabilitation with adults who have experienced hip fracture, in preparation for a larger randomized controlled study. A one-group (N=6) pre-test/post-test design is currently being constructed. Results of the pilot study will be used to determine what adaptations to the design may be required to ensure successful implementation. Recruitment, retention and attendance rates, as well as percentages completing the outcome measures, will be examined to plan the time frame of the main trial. The intervention will include 10 videoconferencing 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

October 3, 2017

Status Verified

September 1, 2017

Enrollment Period

1.5 years

First QC Date

September 18, 2017

Last Update Submit

September 27, 2017

Conditions

Keywords

telerehabilitationoccupational therapyrctparticipationquality of lifeinterventionolder 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 (1)

telerehabilitation

EXPERIMENTAL

Telerehabilitation refers to the use of technologies to provide rehabilitation services to people in their homes. The intervention will be performed by real-time video-conferencing using an iPad® and Skype™, a software program that allows video calls over the Internet

Behavioral: Cognitive Orientation to Occupational Performance

Interventions

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

telerehabilitation

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herzog Hospital

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 18, 2017

First Posted

October 3, 2017

Study Start

January 1, 2017

Primary Completion

June 30, 2018

Study Completion

March 31, 2019

Last Updated

October 3, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations