xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06014554</url>
    </required_header>
    <id_info>
      <org_study_id>312631</org_study_id>
      <nct_id>NCT06014554</nct_id>
    </id_info>
    <brief_title>Structured Tailored Rehabilitation After Hip Fragility Fracture</brief_title>
    <acronym>STRATIFY</acronym>
    <official_title>Structured Tailored Rehabilitation After Hip Fragility Fracture: The 'STRATIFY' Feasibility Randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>King's College London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>UK Research and Innovation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>King's College London</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Why the investigators are doing this study? The best approach to rehabilitation after a&#xD;
        broken hip is not known. A new approach could improve outcomes by tailoring rehabilitation to&#xD;
        patient needs. This approach identifies subgroups of patients within a population who have&#xD;
        different risks of poor outcomes. These subgroups are then matched to treatments better&#xD;
        tailored to their needs. Survivors of a broken hip describe a tailored approach as key to&#xD;
        recovery. Further, the NHS recommends this approach as central to healthcare progress.&#xD;
  &#xD;
        This study wants to see if it is possible for the NHS to deliver this new approach to&#xD;
        rehabilitation for older adults who break their hip.&#xD;
  &#xD;
        What will be done? The investigators worked with patients to plan this study. Patients will&#xD;
        keep helping the investigators during the study. Sixty older people who had surgery to fix a&#xD;
        broken hip will be invited to take part. Participants will be given a level of risk (low,&#xD;
        medium, or high) based on an online calculator (www.stratifyhip.co.uk).&#xD;
  &#xD;
        All 60 participants will get usual care provided locally. Half, selected by chance, will get&#xD;
        extra rehabilitation during their hospital stay including a self-managed exercise programme&#xD;
        for the low-risk subgroup, education, a goal-orientated mobility programme and enhanced&#xD;
        discharge planning for the medium-risk subgroup, and education, a goal-orientated activity of&#xD;
        daily living programme, orientation, and enhanced assessment for the high-risk subgroup.&#xD;
  &#xD;
        The investigators will collect information from the 60 people taking part, at the beginning,&#xD;
        middle, and end of the study and again 12- weeks later.&#xD;
  &#xD;
        What will the next step be? If this small study shows this extra rehabilitation can be&#xD;
        provided in the NHS, and it may help patients, then the investigators plan to do a larger&#xD;
        study. The larger study will see if this extra rehabilitation works to help older people get&#xD;
        back home and feel happier.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Each year, United Kingdom (UK) hospitals admit 70,000 men and women over the age of 60 years&#xD;
        with hip fracture. Even with surgery, 30% of patients die within a year. Among survivors, 25%&#xD;
        never walk again, and 22% transition from independent living to nursing homes. This led 81&#xD;
        global societies to endorse a call to action to improve acute multidisciplinary care after&#xD;
        hip fracture.&#xD;
  &#xD;
        A recent Cochrane systematic review supports rehabilitation in hospital as an effective&#xD;
        approach to reduce mortality after hip fracture. However, the nature of the rehabilitation&#xD;
        interventions varied considerably limiting conclusions on the optimal components. This&#xD;
        uncertainty has translated to NICE guidance being limited to daily mobilisation and regular&#xD;
        physiotherapy review.&#xD;
  &#xD;
        The generalisability of the evidence is also limited as many rehabilitation trials attempted&#xD;
        to account for differences in the hip fracture population by targeting homogenous subgroups&#xD;
        such as patients with cognitive impairment, women, or from nursing homes. It is therefore&#xD;
        uncertain whether interventions deemed 'effective' are so for all patients, or for the&#xD;
        targeted subgroup. This in turn poses challenges as to how these interventions may be&#xD;
        implemented when subgroups compete for finite National Health Service (NHS) resources.&#xD;
  &#xD;
        An intervention based on stratified rehabilitation may provide answers to these&#xD;
        uncertainties. Stratified rehabilitation considers an entire population competing for&#xD;
        resources to identify subgroups of patients with different risk of poor outcomes. Subgroups&#xD;
        are then matched to rehabilitation tailored to their needs to optimise outcomes across the&#xD;
        entire population. Hip fracture survivors recently described this tailored approach as key to&#xD;
        successful recovery. Further, a stratified approach is regarded central to the progress of&#xD;
        healthcare according to the NHS and House of Lords Science and Technology Committee. Although&#xD;
        an approach of matching rehabilitation to patient subgroups with different risks of poor&#xD;
        outcomes is intuitive and effective for other conditions, it has not been tested for&#xD;
        rehabilitation after hip fracture.&#xD;
  &#xD;
        A stratified approach to rehabilitation after hip fracture was subsequently developed. The&#xD;
        study has been designed in collaboration with patients and carers, healthcare professionals&#xD;
        working in the hospital setting, health services researchers and statisticians. The protocol&#xD;
        has been scientifically appraised through the funding application process (with external peer&#xD;
        review) and by experts in the field of orthogeriatric rehabilitation research.&#xD;
  &#xD;
        First, the investigators developed and validated a subgrouping tool 'the stratify hip&#xD;
        algorithm' (based on three multivariable prediction models) to identify patients at low-,&#xD;
        intermediate- and high-risk of death and/or change in residence (to a higher level of care)&#xD;
        using records for over 170,000 patients admitted to one of 173 hospitals in England and&#xD;
        Wales. The approach requires website entry of 5 pieces of information (age, sex, prefracture&#xD;
        mobility, prefracture residence, and dementia diagnosis) to generate a risk assignment.&#xD;
  &#xD;
        Next matched interventions were designed for each subgroup identified by the algorithm. These&#xD;
        interventions were informed by qualitative interviews with patients, physiotherapists, and&#xD;
        the multidisciplinary team, an umbrella review of systematic reviews of older adults who&#xD;
        underwent rehabilitation interventions in the acute setting, recent systematic (including&#xD;
        Cochrane) reviews, international guidelines, consultation with our public and patient&#xD;
        involvement group 'TROOP' (further detail of TROOP available at www.ppitroop.co.uk), and an&#xD;
        intervention development workshop and survey (following a nominal group technique) to&#xD;
        prioritize components with key stakeholders. The interventions comprise self-managed exercise&#xD;
        (low risk subgroup); education, a goal orientated mobility programme, and enhanced discharge&#xD;
        planning (medium risk subgroup); and education, a goal orientated activities of daily living&#xD;
        programme, and enhanced assessment (high risk subgroup). Carers of participants in the medium&#xD;
        and high risk subgroups will be invited to take part to receive training in supporting&#xD;
        participants with their programmes.&#xD;
  &#xD;
        The overarching purpose of a future main study is to determine the clinical- and&#xD;
        cost-effectiveness of adding an intervention to usual care designed to improve outcomes of&#xD;
        acute care for older adults after hip fracture. Several uncertainties will first be addressed&#xD;
        through this randomised feasibility trial.&#xD;
  &#xD;
        The primary objective of this feasibility and pilot randomised trial is to determine the&#xD;
        treatment fidelity of the proposed intervention.&#xD;
  &#xD;
        Secondary objectives seek to determine:&#xD;
  &#xD;
          1. The acceptability of the intervention to participants, carers and therapists.&#xD;
  &#xD;
          2. Barriers and enablers to intervention delivery.&#xD;
  &#xD;
          3. Count of screened, eligible, approached, recruited and retained participants (and&#xD;
             carers).&#xD;
  &#xD;
          4. Acceptability, completeness, and descriptive comparison of outcome data collection.&#xD;
  &#xD;
          5. Count of inadvertent unblinding of outcome assessors.&#xD;
  &#xD;
          6. Count of adverse events (AE) and serious adverse events (SAE).&#xD;
  &#xD;
          7. Indicative sample size for a definitive trial.&#xD;
  &#xD;
        Sixty participants will be recruited (30 per treatment arm) with assessments at baseline,&#xD;
        intervention end, and 12-week follow up. The intervention will start within 72 hours of&#xD;
        surgery and end on discharge from the acute hospital. Feasibility criteria have been&#xD;
        specified a priori to determine whether the trial will progress to a definitive trial.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Treatment fidelity (supervised intervention)</measure>
      <time_frame>At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days)</time_frame>
      <description>measured through assessment of treatment logs</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Treatment fidelity (unsupervised intervention)</measure>
      <time_frame>At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days)</time_frame>
      <description>measured through assessment of patient diary</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Count of screened, eligibly, approached, recruited and retained participants</measure>
      <time_frame>screening through to 12-week follow-up</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability of intervention to participants, carers and therapists</measure>
      <time_frame>At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days)</time_frame>
      <description>collected via semi-structured interviews</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Barriers and enablers to intervention delivery</measure>
      <time_frame>At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days)</time_frame>
      <description>collected via semi-structured interviews with participants, carers and therapists</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability and completeness of EuroQoL EQ-5D-5L</measure>
      <time_frame>Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up</time_frame>
      <description>health-related quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability and completeness of Barthel Index</measure>
      <time_frame>Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up</time_frame>
      <description>activities of daily living</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability and completeness of Nottingham Extended Activities of Daily Living</measure>
      <time_frame>Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up</time_frame>
      <description>activities of daily living</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability and completeness of Short Falls Efficacy Scale-International</measure>
      <time_frame>Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up</time_frame>
      <description>falls related self-efficacy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability and completeness of Numeric Rating Scale</measure>
      <time_frame>Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up</time_frame>
      <description>Pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability and completeness of New Mobility Score</measure>
      <time_frame>Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up</time_frame>
      <description>Walking ability</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability and completeness of University of Alabama Life Space Assessment</measure>
      <time_frame>Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up</time_frame>
      <description>Walking ability</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability and completeness of non-validated resource use questionnaire</measure>
      <time_frame>Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Completeness of Length of stay</measure>
      <time_frame>At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Completeness of Mortality</measure>
      <time_frame>At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Completeness of Living status</measure>
      <time_frame>Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up</time_frame>
      <description>lives alone, with independent spouse, with dependent spouse, with family, with other</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Completeness of Readmission</measure>
      <time_frame>12-week follow-up</time_frame>
      <description>Readmission to hospital (for any cause) following discharge after hip fracture surgery. The cause of readmission will be documented.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Count of inadvertent unblinding of outcome assessors</measure>
      <time_frame>At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Count of adverse and serious adverse events</measure>
      <time_frame>From randomisation to 12-week follow-up</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Hip Fractures</condition>
    <arm_group>
      <arm_group_label>Stratify</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients randomised to the 'Stratify' intervention will receive usual care and an intervention based on their subgroup assignment. The intervention will start before the third postoperative day and be delivered during the inpatient stay. Intervention components will be delivered by a physiotherapist, occupational therapist, or therapy assistant depending on staffing availability.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual care</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patients randomised to the control arm will receive usual physiotherapy and occupational therapy care.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Low-risk subgroup</intervention_name>
      <description>Self-managed exercise programme.</description>
      <arm_group_label>Stratify</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Medium-risk subgroup</intervention_name>
      <description>Education, goal-orientated mobility programme, and enhanced discharge planning.</description>
      <arm_group_label>Stratify</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>High-risk subgroup</intervention_name>
      <description>Education, enhanced assessment, orientation, and goal-orientated activities of daily living training programme.</description>
      <arm_group_label>Stratify</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control group</intervention_name>
      <description>Usual care entails physiotherapy and occupational therapy from the day after surgery to the point of discharge, with a focus on discharge planning and sufficient recovery of activities of daily living and mobility for safe return to prefracture residence.</description>
      <arm_group_label>Usual care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria: We will include adults&#xD;
  &#xD;
            -  aged 60 years or more.&#xD;
  &#xD;
            -  admitted to hospital for surgical repair of a hip fracture.&#xD;
  &#xD;
            -  who are willing and able to provide consent or assent depending on the level of&#xD;
               cognitive impairment.&#xD;
  &#xD;
          Exclusion Criteria: We will exclude adults&#xD;
  &#xD;
            -  less than 60 years, to align with the National Hip Fracture Databases definition of&#xD;
               the target population.&#xD;
  &#xD;
            -  not surgically treated, as this treatment approach is reserved for around 2% of&#xD;
               patients in the UK who are often at the end of life.&#xD;
  &#xD;
            -  who broke their hip in hospital following admission for a different illness/injury as&#xD;
               their anticipated care pathway and outcomes will vary from those who are admitted for&#xD;
               hip fracture.&#xD;
  &#xD;
            -  participating in other treatment trials and without agreement of both trial teams.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Katie J Sheehan, PhD</last_name>
      <phone>+44 (0)20 7123 4843</phone>
      <email>katie.sheehan@kcl.ac.uk</email>
    </overall_contact>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>neck of femur</keyword>
    <keyword>fragility fracture</keyword>
    <keyword>rehabilitation</keyword>
    <keyword>stratified care</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fractures, Bone</mesh_term>
      <mesh_term>Hip Fractures</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>An anonymised dataset will be preserved on the King's Open Research Data System. This dataset will include anonymised data collected which does not breach any agreement for outcome measure use.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Following publication of the primary paper, an anonymised dataset will be preserved indefinitely on the King's Open Research Data System.</ipd_time_frame>
      <ipd_access_criteria>Proof of ethical approval as a condition of access.</ipd_access_criteria>
      <ipd_url>https://www.kcl.ac.uk/researchsupport/managing/preserve</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06014554
  org study id: 312631
  nct id: NCT06014554
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Why the investigators are doing this study? The best approach to rehabilitation after a
        broken hip is not known. A new approach could improve outcomes by tailoring rehabilitation to
        patient needs. This approach identifies subgroups of patients within a population who have
        different risks of poor outcomes. These subgroups are then matched to treatments better
        tailored to their needs. Survivors of a broken hip describe a tailored approach as key to
        recovery. Further, the NHS recommends this approach as central to healthcare progress.
  
        This study wants to see if it is possible for the NHS to deliver this new approach to
        rehabilitation for older adults who break their hip.
  
        What will be done? The investigators worked with patients to plan this study. Patients will
        keep helping the investigators during the study. Sixty older people who had surgery to fix a
        broken hip will be invited to take part. Participants will be given a level of risk (low,
        medium, or high) based on an online calculator (www.stratifyhip.co.uk).
  
        All 60 participants will get usual care provided locally. Half, selected by chance, will get
        extra rehabilitation during their hospital stay including a self-managed exercise programme
        for the low-risk subgroup, education, a goal-orientated mobility programme and enhanced
        discharge planning for the medium-risk subgroup, and education, a goal-orientated activity of
        daily living programme, orientation, and enhanced assessment for the high-risk subgroup.
  
        The investigators will collect information from the 60 people taking part, at the beginning,
        middle, and end of the study and again 12- weeks later.
  
        What will the next step be? If this small study shows this extra rehabilitation can be
        provided in the NHS, and it may help patients, then the investigators plan to do a larger
        study. The larger study will see if this extra rehabilitation works to help older people get
        back home and feel happier.
  Each year, United Kingdom (UK) hospitals admit 70,000 men and women over the age of 60 years
        with hip fracture. Even with surgery, 30% of patients die within a year. Among survivors, 25%
        never walk again, and 22% transition from independent living to nursing homes. This led 81
        global societies to endorse a call to action to improve acute multidisciplinary care after
        hip fracture.
  
        A recent Cochrane systematic review supports rehabilitation in hospital as an effective
        approach to reduce mortality after hip fracture. However, the nature of the rehabilitation
        interventions varied considerably limiting conclusions on the optimal components. This
        uncertainty has translated to NICE guidance being limited to daily mobilisation and regular
        physiotherapy review.
  
        The generalisability of the evidence is also limited as many rehabilitation trials attempted
        to account for differences in the hip fracture population by targeting homogenous subgroups
        such as patients with cognitive impairment, women, or from nursing homes. It is therefore
        uncertain whether interventions deemed 'effective' are so for all patients, or for the
        targeted subgroup. This in turn poses challenges as to how these interventions may be
        implemented when subgroups compete for finite National Health Service (NHS) resources.
  
        An intervention based on stratified rehabilitation may provide answers to these
        uncertainties. Stratified rehabilitation considers an entire population competing for
        resources to identify subgroups of patients with different risk of poor outcomes. Subgroups
        are then matched to rehabilitation tailored to their needs to optimise outcomes across the
        entire population. Hip fracture survivors recently described this tailored approach as key to
        successful recovery. Further, a stratified approach is regarded central to the progress of
        healthcare according to the NHS and House of Lords Science and Technology Committee. Although
        an approach of matching rehabilitation to patient subgroups with different risks of poor
        outcomes is intuitive and effective for other conditions, it has not been tested for
        rehabilitation after hip fracture.
  
        A stratified approach to rehabilitation after hip fracture was subsequently developed. The
        study has been designed in collaboration with patients and carers, healthcare professionals
        working in the hospital setting, health services researchers and statisticians. The protocol
        has been scientifically appraised through the funding application process (with external peer
        review) and by experts in the field of orthogeriatric rehabilitation research.
  
        First, the investigators developed and validated a subgrouping tool 'the stratify hip
        algorithm' (based on three multivariable prediction models) to identify patients at low-,
        intermediate- and high-risk of death and/or change in residence (to a higher level of care)
        using records for over 170,000 patients admitted to one of 173 hospitals in England and
        Wales. The approach requires website entry of 5 pieces of information (age, sex, prefracture
        mobility, prefracture residence, and dementia diagnosis) to generate a risk assignment.
  
        Next matched interventions were designed for each subgroup identified by the algorithm. These
        interventions were informed by qualitative interviews with patients, physiotherapists, and
        the multidisciplinary team, an umbrella review of systematic reviews of older adults who
        underwent rehabilitation interventions in the acute setting, recent systematic (including
        Cochrane) reviews, international guidelines, consultation with our public and patient
        involvement group 'TROOP' (further detail of TROOP available at www.ppitroop.co.uk), and an
        intervention development workshop and survey (following a nominal group technique) to
        prioritize components with key stakeholders. The interventions comprise self-managed exercise
        (low risk subgroup); education, a goal orientated mobility programme, and enhanced discharge
        planning (medium risk subgroup); and education, a goal orientated activities of daily living
        programme, and enhanced assessment (high risk subgroup). Carers of participants in the medium
        and high risk subgroups will be invited to take part to receive training in supporting
        participants with their programmes.
  
        The overarching purpose of a future main study is to determine the clinical- and
        cost-effectiveness of adding an intervention to usual care designed to improve outcomes of
        acute care for older adults after hip fracture. Several uncertainties will first be addressed
        through this randomised feasibility trial.
  
        The primary objective of this feasibility and pilot randomised trial is to determine the
        treatment fidelity of the proposed intervention.
  
        Secondary objectives seek to determine:
  
          1. The acceptability of the intervention to participants, carers and therapists.
  
          2. Barriers and enablers to intervention delivery.
  
          3. Count of screened, eligible, approached, recruited and retained participants (and
             carers).
  
          4. Acceptability, completeness, and descriptive comparison of outcome data collection.
  
          5. Count of inadvertent unblinding of outcome assessors.
  
          6. Count of adverse events (AE) and serious adverse events (SAE).
  
          7. Indicative sample size for a definitive trial.
  
        Sixty participants will be recruited (30 per treatment arm) with assessments at baseline,
        intervention end, and 12-week follow up. The intervention will start within 72 hours of
        surgery and end on discharge from the acute hospital. Feasibility criteria have been
        specified a priori to determine whether the trial will progress to a definitive trial.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: Single (Outcomes Assessor)
  measure: Treatment fidelity (supervised intervention)
  time frame: At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days)
  description: measured through assessment of treatment logs
  measure: Treatment fidelity (unsupervised intervention)
  time frame: At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days)
  description: measured through assessment of patient diary
  measure: Count of screened, eligibly, approached, recruited and retained participants
  time frame: screening through to 12-week follow-up
  measure: Acceptability of intervention to participants, carers and therapists
  time frame: At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days)
  description: collected via semi-structured interviews
  measure: Barriers and enablers to intervention delivery
  time frame: At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days)
  description: collected via semi-structured interviews with participants, carers and therapists
  measure: Acceptability and completeness of EuroQoL EQ-5D-5L
  time frame: Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up
  description: health-related quality of life
  measure: Acceptability and completeness of Barthel Index
  time frame: Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up
  description: activities of daily living
  measure: Acceptability and completeness of Nottingham Extended Activities of Daily Living
  time frame: Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up
  description: activities of daily living
  measure: Acceptability and completeness of Short Falls Efficacy Scale-International
  time frame: Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up
  description: falls related self-efficacy
  measure: Acceptability and completeness of Numeric Rating Scale
  time frame: Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up
  description: Pain
  measure: Acceptability and completeness of New Mobility Score
  time frame: Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up
  description: Walking ability
  measure: Acceptability and completeness of University of Alabama Life Space Assessment
  time frame: Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up
  description: Walking ability
  measure: Acceptability and completeness of non-validated resource use questionnaire
  time frame: Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up
  measure: Completeness of Length of stay
  time frame: At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days)
  measure: Completeness of Mortality
  time frame: At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up
  measure: Completeness of Living status
  time frame: Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up
  description: lives alone, with independent spouse, with dependent spouse, with family, with other
  measure: Completeness of Readmission
  time frame: 12-week follow-up
  description: Readmission to hospital (for any cause) following discharge after hip fracture surgery. The cause of readmission will be documented.
  measure: Count of inadvertent unblinding of outcome assessors
  time frame: At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up
  measure: Count of adverse and serious adverse events
  time frame: From randomisation to 12-week follow-up
  arm group label: Stratify
  arm group type: Experimental
  description: Patients randomised to the 'Stratify' intervention will receive usual care and an intervention based on their subgroup assignment. The intervention will start before the third postoperative day and be delivered during the inpatient stay. Intervention components will be delivered by a physiotherapist, occupational therapist, or therapy assistant depending on staffing availability.
  arm group label: Usual care
  arm group type: Placebo Comparator
  description: Patients randomised to the control arm will receive usual physiotherapy and occupational therapy care.
  intervention type: Other
  intervention name: Low-risk subgroup
  description: Self-managed exercise programme.
  arm group label: Stratify
  intervention type: Other
  intervention name: Medium-risk subgroup
  description: Education, goal-orientated mobility programme, and enhanced discharge planning.
  arm group label: Stratify
  intervention type: Other
  intervention name: High-risk subgroup
  description: Education, enhanced assessment, orientation, and goal-orientated activities of daily living training programme.
  arm group label: Stratify
  intervention type: Other
  intervention name: Control group
  description: Usual care entails physiotherapy and occupational therapy from the day after surgery to the point of discharge, with a focus on discharge planning and sufficient recovery of activities of daily living and mobility for safe return to prefracture residence.
  arm group label: Usual care
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Katie J Sheehan, PhD
  phone: +44 (0)20 7123 4843
  email: katie.sheehan@kcl.ac.uk
  responsible party type: Sponsor
  mesh term: Fractures, Bone
  mesh term: Hip Fractures
  sharing ipd: Yes
  ipd description: An anonymised dataset will be preserved on the King's Open Research Data System. This dataset will include anonymised data collected which does not breach any agreement for outcome measure use.
  ipd info type: Study Protocol
  ipd time frame: Following publication of the primary paper, an anonymised dataset will be preserved indefinitely on the King's Open Research Data System.
  ipd access criteria: Proof of ethical approval as a condition of access.
  ipd url: https://www.kcl.ac.uk/researchsupport/managing/preserve