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Trial record 14 of 114 for:    Recruiting, Not yet recruiting, Available Studies | "Hip Fractures"

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

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ClinicalTrials.gov Identifier: NCT03376750
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Collaborators:
Hebrew University of Jerusalem
Israel National Institute for Health Policy and Health Services Research
Information provided by (Responsible Party):
Yakir Kaufman, Herzog Hospital

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


Condition or disease Intervention/treatment Phase
Hip Fractures Behavioral: CO - OP Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: three-arm randomized control trail (RCT) including pre/post intervention and follow-up
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Tele-rehabilitation Intervention to Improve Performance and Reduce Morbidity for People Post Hip Fracture - Randomized Controlled Trial
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CO - OP via telerehabilitation + standard care
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 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
Other Name: Cognitive Orientation to Occupational Performance

Experimental: CO - OP via face to face + standard care
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
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
Other Name: Cognitive Orientation to Occupational Performance

No Intervention: control group - standard care
standard care as given from public health service



Primary Outcome Measures :
  1. Change from baseline at post intervention in The Canadian Occupational Performance Measure (COPM) [ Time Frame: Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months ]
    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 :
  1. Functional Independence Measure (FIM) [ Time Frame: Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months ]
    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

  2. The Geriatric Depression Scale (GDS) [ Time Frame: Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months ]
    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.

  3. 12-item MOS Short-Form Health Status Survey, Hebrew version [ Time Frame: Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months ]
    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

  4. The Zarit Caregiver Burden Interview [ Time Frame: Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months ]
    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

  5. Qualitative interview [ Time Frame: post 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



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376750


Contacts
Contact: Yafit Gilboa, OTphD +972523362230 yafitgilboa@yahoo.com
Contact: Talia Maeir, BOT +972547866338 taliabengigi@gmail.com

Locations
Israel
Herzog Hospital Recruiting
Jerusalem, Israel
Contact: Yakir Kaufmam, MD    +972545703130    ykaufman@herzoghospital.org   
Sponsors and Collaborators
Herzog Hospital
Hebrew University of Jerusalem
Israel National Institute for Health Policy and Health Services Research
Investigators
Study Director: Yafit Gilboa, OTphD School of Occupational Therapy, Faculty of Medicine Hadassah and the Hebrew University of Jerusalem

Responsible Party: Yakir Kaufman, MD, Herzog Hospital
ClinicalTrials.gov Identifier: NCT03376750     History of Changes
Other Study ID Numbers: HerzogH RCT
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yakir Kaufman, Herzog Hospital:
telerehabilitation
occupational therapy
RCT
participation
quality of life
intervention
older adults

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries