NCT03301584

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2014

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
Last Updated

January 6, 2020

Status Verified

January 1, 2020

Enrollment Period

10 months

First QC Date

September 22, 2017

Last Update Submit

January 3, 2020

Conditions

Keywords

Hip fractureADLpatient participationfunctional balancephysical performance

Outcome Measures

Primary Outcomes (1)

  • Self-rated degree of patient participation in rehabilitation

    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.

    At discharge from in-patienten rehabilitation, on average 14 days

Secondary Outcomes (6)

  • Traffic Light System - BasicADL (TLS-BasicADL)

    At discharge from in-patient rehabilitation, on average 14 days and 1 month follow-up

  • ADL Staircase

    At 1 month follow-up

  • Bergs Balance Scale (BBS)

    At discharge from in-patient rehabilitation, on average 14 days and 1 month follow-up

  • Falls Efficacy Scale (FES-S)

    At discharge from in-patient rehabilitation, on average 14 days and 1 month follow-up

  • Short Physical Performance Battery (SPPB)

    At discharge from in-patient rehabilitation, on average 14 days and 1 month follow-up

  • +1 more secondary outcomes

Study Arms (2)

Enhanced collaboration

ACTIVE COMPARATOR

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

Usual Care Treatment

ACTIVE COMPARATOR

Standard rehabilitation

Other: Usual Care treatment

Interventions

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.

Enhanced collaboration

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.

Usual Care Treatment

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital, Mölndal Hospital

Mölndal, 43180, Sweden

Location

Related Publications (2)

  • Handoll HH, Cameron ID, Mak JC, Panagoda CE, Finnegan TP. Multidisciplinary rehabilitation for older people with hip fractures. Cochrane Database Syst Rev. 2021 Nov 12;11(11):CD007125. doi: 10.1002/14651858.CD007125.pub3.

  • Asplin G, Carlsson G, Ziden L, Kjellby-Wendt G. Early coordinated rehabilitation in acute phase after hip fracture - a model for increased patient participation. BMC Geriatr. 2017 Oct 17;17(1):240. doi: 10.1186/s12877-017-0640-z.

MeSH Terms

Conditions

Hip FracturesPatient Participation

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Lena Zidén, PhD

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2017

First Posted

October 4, 2017

Study Start

September 1, 2013

Primary Completion

June 30, 2014

Study Completion

June 30, 2014

Last Updated

January 6, 2020

Record last verified: 2020-01

Locations