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Early Coordinated Rehabilitation After Hip Fracture

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ClinicalTrials.gov Identifier: NCT03301584
Recruitment Status : Completed
First Posted : October 4, 2017
Last Update Posted : April 24, 2019
Sponsor:
Collaborators:
Axel Linders Stiftelse
SKLs’ äldresatsning
Local Research and Development Fund in Gothenburg and South Bohuslän
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Göteborg University

Brief Summary:

Background Studies have shown that patients with hip fracture treated in a Comprehensive Geriatric Care (CGC) unit report better results in comparison to orthopaedic care. Furthermore, involving patients in their healthcare by encouraging patient participation can result in better quality of care and improved outcomes. To our knowledge no study has been performed comparing rehabilitation programmes within a CGC unit during the acute phase after hip fracture with focus on improving patients' perceived participation and subsequent effect on patients' function.

Method A prospective, controlled, intervention performed in a Comprehensive Geriatric Care (CGC) unit and compared with standard CGC. A total of 126 patients with hip fracture were recruited who were prior to fracture; community dwelling, mobile indoors and independent in personal care. Intervention Group (IG): 63 patients, mean age 82.0 years and Control Group (CG): 63 patients mean age 80.5 years. Intervention: coordinated rehabilitation programme with early onset of patient participation and intensified occupational therapy and physiotherapy after hip fracture surgery. The primary outcome measure was self-reported patient participation at discharge. Secondary outcome measures were: TLS-BasicADL; Bergs Balance Scale (BBS); Falls Efficacy Scale FES(S); Short Physical Performance Battery (SPPB) and Timed Up and Go (TUG) at discharge and 1 month and ADL staircase for instrumental ADL at 1 month.


Condition or disease Intervention/treatment Phase
Hip Fractures Rehabilitation Other: Enhanced collaboration to promote patient participation Other: Usual Care treatment Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective, controlled, intervention study. Evaluation of a modified model of in-patient rehabilitation compared to standard care, with follow-up at 1 month post-discharge.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Coordinated Rehabilitation in Acute Phase After Hip Fracture - a Model for Increased Patient Participation.
Actual Study Start Date : September 1, 2013
Actual Primary Completion Date : June 30, 2014
Actual Study Completion Date : June 30, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Enhanced collaboration

Enhanced OT and PT collaboration to promote patient participation. Goal setting using TLS-BasicADL protocol. Patients were encouraged to consider activities important to them to be able to perform at discharge. Adaption of goals throughout the hospital stay.

Supporting patient self-efficacy: by challenging patients' fear of falling and encouraging progression of exercise.

Training kit with instructions: To increase activity and encourage patients to take more responsibility for their training.

Enhanced exercise with protocol: More intensive training of transfers, walking, balance and P-ADL was offered at least 3 times/day by OT and PT.

Collaboration meetings: twice weekly interdisciplinary meetings plus daily OT and PT logistic meeting to schedule treatment.

Other: Enhanced collaboration to promote patient participation

Enhanced OT and PT collaboration: to promote patient participation. Goal setting using TLS-BasicADL protocol. Patients were encouraged to consider activities important to them to be able to perform at discharge. Adaption of goals throughout the hospital stay.

Supporting patient self-efficacy: by challenging patients' fear of falling and encouraging progression of exercise.

Training kit with instructions: To increase activity and encourage patients to take more responsibility for their training.

Enhanced exercise with protocol: More intensive training of transfers, walking, balance and P-ADL was offered at least 3 times/day by OT and PT.

Collaboration meetings: twice weekly interdisciplinary meetings plus daily OT and PT logistic meeting to schedule treatment.


Active Comparator: Usual Care Treatment
Standard rehabilitation
Other: Usual Care treatment
The control group received standard rehabilitation from occupational therapists and physiotherapists (Monday to Friday), planned individually and gradually progressed for each patient. Mobilisation was initiated within 24 hours after surgery, 7 days a week. Patients were provided with a booklet with information about the fracture, operation method, exercise regime and assistive walking and ADL aid available.




Primary Outcome Measures :
  1. Self-rated degree of patient participation in rehabilitation [ Time Frame: At discharge from in-patienten rehabilitation, on average 14 days ]
    Patients answered 4 questions, specifically formulated for this study, regarding perceived level of participation in; their rehabilitation; working together with OT and PT in goal-setting; personal responsibility for their training, and making decisions regarding care and treatment as much as they liked. The questions were answered using a four level scale; very high degree, moderate degree, small degree or not at all.


Secondary Outcome Measures :
  1. Traffic Light System - BasicADL (TLS-BasicADL) [ Time Frame: At discharge from in-patient rehabilitation, on average 14 days and 1 month follow-up ]
    TLS-BasicADL highlights the patient's level of independence in basic ADL, comprising of 15 different activities; 6 items showing ability to transfer and walk indoors, 7 P-ADL items and 2 additional items; negotiating stairs and walking outdoors. Three colour-coded markers indicate level of dependence; green=independent, yellow=supervision and red=dependent on physical help of others. TLS-BasicADL does not form a composite score but shows through the colour-coding, level of dependence with regard to the patient's; 1) previous ability and assistive aids prior to admission to hospital, 2) present ability and assistive aids used and 3) goals which the patient aims to achieve during inpatient treatment. As the patient's ability to perform activities changes during in-patient rehabilitation, the colour-coded markers are changed correspondingly.

  2. ADL Staircase [ Time Frame: At 1 month follow-up ]

    Ability to perform instrumental activities of daily living was assessed using IADL items of the ADL-staircase.

    The ADL staircase is an expansion of Katz ADL Index of personal activities of daily living, with the addition of four I-ADL items; cooking, shopping, cleaning, and transportation. The ADL staircase uses only two levels; dependent or independent and can be administered through interview and/or observation. The ADL-staircase has shown good validity and reliability, and is considered a stable and clinically relevant when used in studied of older people.


  3. Bergs Balance Scale (BBS) [ Time Frame: At discharge from in-patient rehabilitation, on average 14 days and 1 month follow-up ]
    To measure functional balance and fall risk. BBS assesses 14 activities of varying difficulty with a scoring range from 0-4 (0 unable to perform to 4 able to perform completely). The item scores are summed giving a score of 0-56, with 56 showing indicating normal functional balance. BBS has shown excellent test-retest reliability and validity. To determine clinical significance, minimal detectable change (MDC) scores described by Donoghue & Stokes were used, ranging from 4-7 points depending on baseline score. To discriminate those at risk for falls, a cut-off score of 47 was defined.

  4. Falls Efficacy Scale (FES-S) [ Time Frame: At discharge from in-patient rehabilitation, on average 14 days and 1 month follow-up ]
    Balance confidence was measured using the Swedish version of the Falls Efficacy Scale (FES-S). This version is modified from the original 10-degree scale (1-10) where 1 represents 'very confident, no fear of falling' and 10 'not confident at all, very afraid of falling', into an 11-degree scale (0-10) with a reversed answering alternative (0 not confident at all and 10 totally confident). For the purpose of this study the aspect of confidence rather than fear has been assessed. FES-S includes 13 items, comprising three parts, six items measuring self-care, one item stair walking, and six items instrumental activities. The maximum score is 130. Test-retest reliability of the Swedish version of the scale was found to be acceptable by Hellstrom et al.

  5. Short Physical Performance Battery (SPPB) [ Time Frame: At discharge from in-patient rehabilitation, on average 14 days and 1 month follow-up ]
    Short Physical Performance Battery (SPPB) consists of three components: standing balance, walking speed - timed 4 m walk, and ability to rise from chair. The sum of the three components comprises the final SPPB score with a possible range from 0 to 12 (12 indicating the highest degree of lower extremity functioning). According to Perera et al a small meaningful change is 0.5 and a substantial meaningful change 1.0 point respectively. For analysis of risk for falls a score of ≤ 6 is associated with a higher fall rate.

  6. Timed Up and Go (TUG) [ Time Frame: At discharge from in-patient rehabilitation, on average 14 days and 1 month follow-up ]
    The Timed Up and Go (TUG) test measures ability to perform basic everyday movements. TUG assesses total time for standing up from a standard chair, walking 3m, turning 180 degrees, returning and sitting down. According to recommendations by Podsiadlo and Richardson, TUG was performed twice in each test session, one trial and one timed performance, with a brief seated rest in between. The participants were instructed to walk at a comfortable, safe speed. TUG has good inter-rater and intra-rater reliability and is a reliable and valid measure of functional mobility. A TUG score >24 seconds at discharge, was used for analysis of risk for falls, which is a predictor for falls at 6 months in hip fracture patients.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • presenting with acute hip fracture
  • aged 65 or more
  • able to speak and understand Swedish
  • community dwelling pre-fracture
  • independent walking indoors with or without walking aid and in personal care with exception of bathing/showering.

Exclusion Criteria:

  • severe drug or alcohol abuse
  • mental illness
  • documented cognitive impairment ≤ 8 according to the Short Portable Mental Status Questionnaire (SPMSQ)

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): NCT03301584


Locations
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Sweden
Sahlgrenska University Hospital, Mölndal Hospital
Mölndal, Sweden, 43180
Sponsors and Collaborators
Göteborg University
Axel Linders Stiftelse
SKLs’ äldresatsning
Local Research and Development Fund in Gothenburg and South Bohuslän
Sahlgrenska University Hospital, Sweden
Investigators
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Principal Investigator: Lena Zidén, PhD Göteborg University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03301584     History of Changes
Other Study ID Numbers: FoU in Sweden 62221
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Göteborg University:
Hip fracture
ADL
patient participation
functional balance
physical performance
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries