- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02361580
Impact of Keeping a Personal Recovery Diary on Upper Extremity Disability
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.
Study Overview
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diary
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.
|
Subject keeps diary of recovery
|
No Intervention: No Diary
Control Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Upper Extremity Disability Measured by PROMIS Upper Extremity
Time Frame: 8 weeks
|
Upper Extremity Disability measured by PROMIS Upper Extremity
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Avoidance of Painful Activities Measured by PROMIS Pain Interference
Time Frame: 8 weeks
|
Avoidance of painful activities measured by PROMIS Pain Interference
|
8 weeks
|
Symptoms of Depression Measured by PROMIS Depression
Time Frame: 8 weeks
|
Symptoms of depression measured by PROMIS Depression
|
8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014P002781
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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