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HIP Fracture REhabilitation Programme for Elderly With Hip Fractures (HIP-REP)

Primary Purpose

Hip Fractures

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
HIP fracture REhabilitation Programme for the elderly with hip fractures
Sponsored by
Herlev and Gentofte Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other 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 or Lyngby-Taarbæk municipalities
  • Ability to give informed consent
  • Discharged from hospital and receiving or having received rehabilitation in one municipalities within the last 3 months from onset

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 Type

Other

Arm Label

Enhanced rehabilitation

Arm Description

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, 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.
Occupational Balance Questionnaire
An assessment that measures the patients satisfaction with the amount and variation of occupations; . It consists of 13 items measured on six-step ordinal scales. The patient chooses one of those: Disagree, partly disagree, partly agree or agree.
Satisfaction with daily occupations
An instrument measuring satisfaction with everyday occupations addressing four areas of everyday occupations: work and work-related occupations, leisure occupations, domestic occupations and self-care. The patient chooses on a scale from 1 to 7. 1 = Not satisfied to 7 = Very satisfied.
Cumulated Ambulation Score
The Cumulated Ambulation Score is evaluating patients' basic mobility (getting in and out of bed, sit-to-stand from a chair and walking). Each of the three activities is scored from 0-2, resulting in a daily score of 0-6.
New Mobility Score
The New Mobility Score is a composite score of the patient's ability to perform: indoor walking, outdoor walking and shopping, providing a score between zero and three (0: not at all, 1: with help from another person, 2: with an aid, 3: no difficulty) for each function, resulting in a total score from 0 to 9, with nine indicating a high prefracture functional level.
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 100 percent.

Full Information

First Posted
January 29, 2019
Last Updated
September 5, 2019
Sponsor
Herlev and Gentofte Hospital
Collaborators
Municipality of Herlev, Municipality of Lyngby-Taarbæk, Municipality of Gentofte, Copenhagen University Hospital at Herlev, 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
NCT03828240
Brief Title
HIP Fracture REhabilitation Programme for Elderly With Hip Fractures
Acronym
HIP-REP
Official Title
HIP Fracture REhabilitation Programme for Elderly With Hip Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev and Gentofte Hospital
Collaborators
Municipality of Herlev, Municipality of Lyngby-Taarbæk, Municipality of Gentofte, Copenhagen University Hospital at Herlev, 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 feasibility of a HIP fracture REhabilitation Programme (HIP-REP).This study will investigate adherence, satisfaction, technical and practical circumstances regarding implementation and taking this into account when evaluating the feasibility of the HIP-REP program. Hypothesis: By testing the feasibility of a HIP-REP for the participants and the usefulness of the selected measurement tools, the investigators will be able to evaluate and adjust the HIP-REP before evaluating this in a larger Randomized controlled trial (RCT).
Detailed Description
Little is known about the feasibility and 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 Quality of Life (QoL). Therefore, the investigators want to evaluate whether an activity-based rehabilitation intervention across sectors is feasible 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
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Activity-based intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced rehabilitation
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
HIP fracture REhabilitation Programme for the elderly with hip fractures
Intervention Description
Eight-week activity-based intervention for elderly with hip fractures; one intervention during the hospital stay, four interventions at the elderly's municipality.
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, In all, 36 discrete ratings of motor and process skills are made during observation.
Time Frame
Change from baseline at motor and process skills 3 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 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 months after baseline testing
Title
Occupational Balance Questionnaire
Description
An assessment that measures the patients satisfaction with the amount and variation of occupations; . It consists of 13 items measured on six-step ordinal scales. The patient chooses one of those: Disagree, partly disagree, partly agree or agree.
Time Frame
at baseline and 3 months after baseline testing
Title
Satisfaction with daily occupations
Description
An instrument measuring satisfaction with everyday occupations addressing four areas of everyday occupations: work and work-related occupations, leisure occupations, domestic occupations and self-care. The patient chooses on a scale from 1 to 7. 1 = Not satisfied to 7 = Very satisfied.
Time Frame
at baseline and 3 months after baseline testing
Title
Cumulated Ambulation Score
Description
The Cumulated Ambulation Score is evaluating patients' basic mobility (getting in and out of bed, sit-to-stand from a chair and walking). Each of the three activities is scored from 0-2, resulting in a daily score of 0-6.
Time Frame
at baseline
Title
New Mobility Score
Description
The New Mobility Score is a composite score of the patient's ability to perform: indoor walking, outdoor walking and shopping, providing a score between zero and three (0: not at all, 1: with help from another person, 2: with an aid, 3: no difficulty) for each function, resulting in a total score from 0 to 9, with nine indicating a high prefracture functional level.
Time Frame
at baseline and 3 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 100 percent.
Time Frame
at baseline and 3 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 or Lyngby-Taarbæk municipalities Ability to give informed consent Discharged from hospital and receiving or having received rehabilitation in one municipalities within the last 3 months from onset 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
35477380
Citation
Ropke A, Morville AL, Moller TE, Delkus ECG, Juhl CB. HIP Fracture REhabilitation Program for older adults with hip fracture (HIP-REP) based on activity of daily living: a feasibility study. BMC Geriatr. 2022 Apr 27;22(1):370. doi: 10.1186/s12877-022-03039-x.
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 for Elderly With Hip Fractures

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