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

Primary Purpose

Hip Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
CO - OP
Sponsored by
Herzog Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring telerehabilitation, occupational therapy, RCT, participation, quality of life, intervention, older adults

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Herzog HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

CO - OP via telerehabilitation + standard care

CO - OP via face to face + standard care

control group - standard care

Arm Description

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.

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.

standard care as given from public health service

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Functional Independence Measure (FIM)
The 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)
The 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 version
This 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 Interview
The 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 interview
Semi-structured interviews will be conducted post intervention with the patients and their caregivers to identify barriers and facilitators regarding the intervention

Full Information

First Posted
December 13, 2017
Last Updated
December 15, 2017
Sponsor
Herzog Hospital
Collaborators
Hebrew University of Jerusalem, Israel National Institute for Health Policy and Health Services Research
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1. Study Identification

Unique Protocol Identification Number
NCT03376750
Brief Title
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

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Anticipated)
Study Completion Date
March 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herzog Hospital
Collaborators
Hebrew University of Jerusalem, Israel National Institute for Health Policy and Health Services Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
telerehabilitation, occupational therapy, RCT, participation, quality of life, intervention, older adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
three-arm randomized control trail (RCT) including pre/post intervention and follow-up
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CO - OP via telerehabilitation + standard care
Arm Type
Experimental
Arm Description
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.
Arm Title
CO - OP via face to face + standard care
Arm Type
Experimental
Arm Description
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.
Arm Title
control group - standard care
Arm Type
No Intervention
Arm Description
standard care as given from public health service
Intervention Type
Behavioral
Intervention Name(s)
CO - OP
Other Intervention Name(s)
Cognitive Orientation to Occupational Performance
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline at post intervention in The Canadian Occupational Performance Measure (COPM)
Description
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
Time Frame
Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months
Secondary Outcome Measure Information:
Title
Functional Independence Measure (FIM)
Description
The 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
Time Frame
Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months
Title
The Geriatric Depression Scale (GDS)
Description
The 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.
Time Frame
Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months
Title
12-item MOS Short-Form Health Status Survey, Hebrew version
Description
This 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
Time Frame
Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months
Title
The Zarit Caregiver Burden Interview
Description
The 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
Time Frame
Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months
Title
Qualitative interview
Description
Semi-structured interviews will be conducted post intervention with the patients and their caregivers to identify barriers and facilitators regarding the intervention
Time Frame
post intervention, 10 weeks (T1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yafit Gilboa, OTphD
Phone
+972523362230
Email
yafitgilboa@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Talia Maeir, BOT
Phone
+972547866338
Email
taliabengigi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yafit Gilboa, OTphD
Organizational Affiliation
School of Occupational Therapy, Faculty of Medicine Hadassah and the Hebrew University of Jerusalem
Official's Role
Study Director
Facility Information:
Facility Name
Herzog Hospital
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yakir Kaufmam, MD
Phone
+972545703130
Email
ykaufman@herzoghospital.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31109289
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.
Results Reference
derived

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

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