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Impact of Keeping a Personal Recovery Diary on Upper Extremity Disability

Primary Purpose

Acute Injury of Upper Extremity

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diary
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Injury of Upper Extremity

Eligibility Criteria

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

Inclusion Criteria:

  • All new patients (>18 years) with an acute injury of the upper extremity (fracture, laceration, sprain, contusion)
  • English fluency and literacy
  • Able to take informed consent

Exclusion Criteria:

  • Pregnant women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Diary

    No Diary

    Arm Description

    Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.

    Control Group

    Outcomes

    Primary Outcome Measures

    Upper Extremity Disability Measured by PROMIS Upper Extremity
    Upper Extremity Disability measured by PROMIS Upper Extremity

    Secondary Outcome Measures

    Avoidance of Painful Activities Measured by PROMIS Pain Interference
    Avoidance of painful activities measured by PROMIS Pain Interference
    Symptoms of Depression Measured by PROMIS Depression
    Symptoms of depression measured by PROMIS Depression

    Full Information

    First Posted
    February 6, 2015
    Last Updated
    February 8, 2017
    Sponsor
    Massachusetts General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02361580
    Brief Title
    Impact of Keeping a Personal Recovery Diary on Upper Extremity Disability
    Official Title
    Impact of Keeping a Personal Recovery Diary on Upper Extremity Disability
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Terminated
    Why Stopped
    The Principal Investigator left the institution so the study was stopped before completing enrollment.
    Study Start Date
    January 2015 (Actual)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Primary null hypothesis: • Keeping a personal diary has no effect on upper-extremity disability (assessed w/ PROMIS [Patient Reported Outcome Measurement Information System] upper extremity) 8 weeks after injury. Secondary null hypotheses: Keeping a personal diary has no effect on avoidance of painful activities (assessed w/ PROMIS pain interference) 8 weeks after injury. Keeping a personal diary has no effect on symptoms of depression (assessed w/ PROMIS depression) 8 weeks after injury. There are no factors associated with upper-extremity disability 8 weeks after injury.
    Detailed Description
    Recovery from injury can be counterintuitive and taxing. It is natural to feel protective and prepare for the worst. Healthy exercises can seem unwise. It can seem like things are taking too long or getting off track. We have noticed that small improvements such as being able to resume a cherished activity (e.g. knitting or swimming) or achieving some success with exercises (e.g. obtaining full supination after fracture of the distal radius), can help patients feel like things are going to be okay. That feeling seems to make it easier to do exercises and resume function activities. We wonder if awareness of this process (mindfulness) would help patients recover more rapidly. Keeping a journal is one method for encouraging mindfulness. It allows patients to express themselves and tell their stories. There is evidence that such "narrative medicine" can be healing. We anticipate that patients who perceive little or no progress will be able to look back on how they were feeling earlier on and appreciate that things are moving in the right direction. We also hope that their journal material might be useful for other patients that are having trouble seeing the "light at the end of the tunnel", so as part of this study, we will get permission to use their quotes anonymously in future patient care materials and future research. To our knowledge, research on the impact of keeping a personal diary/journal of recovery is scant, particularly pertaining to recovery from upper extremity trauma. Explanatory variables: Diary or no Diary Diagnosis (fracture, sprain, contusion, skin laceration, complex laceration [tendon, nerve]) Location (hand, wrist, forearm, elbow, arm, shoulder) Sex Age Education Work status Insurance (worker's compensation, private, public, other) Visit type Prior treatment received Other pain conditions Smoking status Marital status Physical or Occupational Therapy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Injury of Upper Extremity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    9 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diary
    Arm Type
    Experimental
    Arm Description
    Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.
    Arm Title
    No Diary
    Arm Type
    No Intervention
    Arm Description
    Control Group
    Intervention Type
    Other
    Intervention Name(s)
    Diary
    Intervention Description
    Subject keeps diary of recovery
    Primary Outcome Measure Information:
    Title
    Upper Extremity Disability Measured by PROMIS Upper Extremity
    Description
    Upper Extremity Disability measured by PROMIS Upper Extremity
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Avoidance of Painful Activities Measured by PROMIS Pain Interference
    Description
    Avoidance of painful activities measured by PROMIS Pain Interference
    Time Frame
    8 weeks
    Title
    Symptoms of Depression Measured by PROMIS Depression
    Description
    Symptoms of depression measured by PROMIS Depression
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All new patients (>18 years) with an acute injury of the upper extremity (fracture, laceration, sprain, contusion) English fluency and literacy Able to take informed consent Exclusion Criteria: Pregnant women
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Ring, MD PhD
    Organizational Affiliation
    Massachusetts General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Impact of Keeping a Personal Recovery Diary on Upper Extremity Disability

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