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

Hip Fractures Clinical Trial

Official title:

Effectiveness of a Tele-rehabilitation Intervention to Improve Performance and Reduce Morbidity for People Post Hip Fracture - Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03376750
• Other study ID #: HerzogH RCT
• Status: Recruiting
• Phase: N/A
• First received: December 13, 2017
• Last updated: December 15, 2017
• Start date: January 1, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: December 2017
• Source: Herzog Hospital
• Contact: Yafit Gilboa, OTphD
• Phone: +972523362230
• Email: yafitgilboa[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 31, 2019
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

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

Locations

Country	Name	City	State
Israel	Herzog Hospital	Jerusalem

Sponsors (3)

Lead Sponsor	Collaborator
Herzog Hospital	Hebrew University of Jerusalem, Israel National Institute for Health Policy and Health Services Research

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months
Secondary	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.	Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months
Secondary	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	Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months
Secondary	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	Baseline-pretest (T0), immediately following intervention (post intervention 10 weeks) (T1), and a 6-month follow-up (T2). in total, 9 months
Secondary	Qualitative interview	Semi-structured interviews will be conducted post intervention with the patients and their caregivers to identify barriers and facilitators regarding the intervention	post intervention, 10 weeks (T1)