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
About this trial
This is an interventional treatment trial for Acute Injury of Upper Extremity
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
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
NCT ID
NCT02361580
First Posted
February 6, 2015
Last Updated
February 8, 2017
Sponsor
Massachusetts General Hospital
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
Learn more about this trial
Impact of Keeping a Personal Recovery Diary on Upper Extremity Disability
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