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HIP Fracture REhabilitation Programme (HIP-REP)

Primary Purpose

Hip Fractures

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
HIP-REP
Usual care
Sponsored by
Carsten Bogh Juhl
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 65 years or older
  • Recent proximal hip fracture (S 72.0 medial femur fracture, S 72.1, pertrochanteric femur fracture, S 72.2 subtrochanteric femur fracture)
  • Living at home prior to hip fracture in Herlev, Gentofte, Furesoe, Rudersdal or Lyngby-Taarbæk municipalities
  • Ability to give informed consent

Exclusion Criteria:

  • Not expected to be discharged to home or rehabilitation centers in the municipality
  • Not able to speak and/or understand Danish
  • Have prior severe physical and /or mental disabilities

Sites / Locations

  • Department of Physiotherapy and Occupational Therapy, Copenhagen University Hospital, Herlev and Gentofte

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Usual care

Arm Description

HIP-REP programme offers elderly with hip fracture add on activity-focused interventions.

The elderly with hip fracture in the control group will receive usual care.

Outcomes

Primary Outcome Measures

Assessment of Motor and Process Skills
The assessment measures the quality of a person's activity of daily living task performance. An observational assessment that allows for evaluation of change in motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living. The instrument consists of 16 motor and 20 process skill abilities that are rated on a 4-point scale. The rating scale is based on the following criteria (Quality of performance); 4 = Competent, 3 = Questionable, 2 = Ineffective or 1 = Severely deficient. In all, 36 discrete ratings of motor and process skills are made during observation.

Secondary Outcome Measures

European Quality of Life Questionnaire
A survey collecting information about health related quality of life comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Verbal Rating Scale
An assessment measuring the intensity of pain. The patient chooses one of those: none, mild, moderate or severe.
Functional Recovery Score
Functional Recovery Score assess the level of function with eleven-items comprised of three main components: basic activities of daily living assessed by four items, instrumental activities of daily living assessed by six items, and mobility assessed by one item. Basic activities of daily living comprise 44 percent of the score; instrumental activities of daily living comprise 23 percent, and mobility comprises 33 percent. Complete independence in basic and instrumental activities of daily living and mobility results in a score of 100percent.

Full Information

First Posted
December 19, 2019
Last Updated
March 15, 2022
Sponsor
Carsten Bogh Juhl
Collaborators
Municipality of Herlev, Municipality of Gentofte, Municipality of Lyngby-Taarbaek, Municipality of Furesoe, Municipality of Rudersdal, Herlev and Gentofte Hospital, Jonkoping University, Intersectoral Research Unit, Metropolitan University College, Danish Association of Occupational Therapist, Danish Regions Development and Research
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1. Study Identification

Unique Protocol Identification Number
NCT04207788
Brief Title
HIP Fracture REhabilitation Programme
Acronym
HIP-REP
Official Title
HIp Fracture REhabilitation Programme for Elderly With Hip Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 28, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Carsten Bogh Juhl
Collaborators
Municipality of Herlev, Municipality of Gentofte, Municipality of Lyngby-Taarbaek, Municipality of Furesoe, Municipality of Rudersdal, Herlev and Gentofte Hospital, Jonkoping University, Intersectoral Research Unit, Metropolitan University College, Danish Association of Occupational Therapist, Danish Regions Development and Research

4. Oversight

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

5. Study Description

Brief Summary
Objectives: To evaluate the effect of a HIP-REP on the quality and independence in ADL ability (performance), measured with the Assessment of Motor and Process Skills (AMPS) and health-related Quality of Life (QoL). Hypothesis: The HIP-REP will increase the quality and independence in ADL performance, measured with AMPS and health-related QoL measure.
Detailed Description
Little is known about the effect of an intersectoral rehabilitation intervention aiming at reducing the decrease in Activities of Daily Living (ADL) ability for elderly with hip fractures. Despite positive surgical outcomes, one-quarter dies within a year after surgery, around eight percent are readmitted to hospital, and just one-third regain their pre-fracture level of physical functioning and ADL ability. After hip fracture, the loss of independence, and further decrease in ADL ability often persists beyond three months after surgery. This increases the risk of social isolation, depression and thus a decrease in QoL. Therefore, the investigators want to evaluate whether an activity-based rehabilitation intervention across sectors is effective and influences this fragile group of patients. The investigators hope to increase the ability to safely and independently perform ADL in elderly with hip fractures, and thereby enhance their health-related QoL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Activity-based intervention
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
HIP-REP programme offers elderly with hip fracture add on activity-focused interventions.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
The elderly with hip fracture in the control group will receive usual care.
Intervention Type
Other
Intervention Name(s)
HIP-REP
Intervention Description
HIP-REP programme is an add on to usual care which includes 5 add on individual activity-focused interventions that will be tailored to the need of elderly with hip fracture in a liaison with the health care professionals. Home visits and follow-up phone call will be a part of programme.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
The elderly in the control group will receive usual rehabilitation. with a focus on mobilization within 24 hours postoperative as an in-patient. In the municipality physiotherapy is offered twice a week for approximately 12 weeks postoperative focusing on neuromotor control over hip, activation and strengthening of muscles as well as increase mobility. When relevant, the elderly receives a home visit by an occupational therapist who assess ADL behaviours, the use of assistive devices and the environmental hazards, preparing and adapting the home environment to prevent falls.
Primary Outcome Measure Information:
Title
Assessment of Motor and Process Skills
Description
The assessment measures the quality of a person's activity of daily living task performance. An observational assessment that allows for evaluation of change in motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living. The instrument consists of 16 motor and 20 process skill abilities that are rated on a 4-point scale. The rating scale is based on the following criteria (Quality of performance); 4 = Competent, 3 = Questionable, 2 = Ineffective or 1 = Severely deficient. In all, 36 discrete ratings of motor and process skills are made during observation.
Time Frame
Change frombaseline at motor and process skills 3 and 6 months after baseline testing
Secondary Outcome Measure Information:
Title
European Quality of Life Questionnaire
Description
A survey collecting information about health related quality of life comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Time Frame
At baseline and 3 and 6 months after baseline testing
Title
Verbal Rating Scale
Description
An assessment measuring the intensity of pain. The patient chooses one of those: none, mild, moderate or severe.
Time Frame
At baseline and 3 and 6 months after baseline testing
Title
Functional Recovery Score
Description
Functional Recovery Score assess the level of function with eleven-items comprised of three main components: basic activities of daily living assessed by four items, instrumental activities of daily living assessed by six items, and mobility assessed by one item. Basic activities of daily living comprise 44 percent of the score; instrumental activities of daily living comprise 23 percent, and mobility comprises 33 percent. Complete independence in basic and instrumental activities of daily living and mobility results in a score of 100percent.
Time Frame
at baseline and 3 and 6 months after baseline testing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 65 years or older Recent proximal hip fracture (S 72.0 medial femur fracture, S 72.1, pertrochanteric femur fracture, S 72.2 subtrochanteric femur fracture) Living at home prior to hip fracture in Herlev, Gentofte, Furesoe, Rudersdal or Lyngby-Taarbæk municipalities Ability to give informed consent Exclusion Criteria: Not expected to be discharged to home or rehabilitation centers in the municipality Not able to speak and/or understand Danish Have prior severe physical and /or mental disabilities
Facility Information:
Facility Name
Department of Physiotherapy and Occupational Therapy, Copenhagen University Hospital, Herlev and Gentofte
City
Copenhagen
State/Province
Herlev
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36070134
Citation
Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.
Results Reference
derived
PubMed Identifier
34145009
Citation
Ropke A, Lund K, Thrane C, Juhl C, Morville AL. Developing an individualised cross-sectoral programme based on activities of daily living to support rehabilitation of older adults with hip fracture: a qualitative study. BMJ Open. 2021 Jun 18;11(6):e044539. doi: 10.1136/bmjopen-2020-044539.
Results Reference
derived

Learn more about this trial

HIP Fracture REhabilitation Programme

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