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

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

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

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Yakir Kaufman, MD, Herzog Hospital
• ClinicalTrials.gov Identifier: NCT03376750
• Other Study ID Numbers: HerzogH RCT
• First Posted: December 18, 2017
• 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