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Impact of Keeping a Personal Recovery Diary on Upper Extremity Disability

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ClinicalTrials.gov Identifier: NCT02361580
Recruitment Status : Terminated (The Principal Investigator left the institution so the study was stopped before completing enrollment.)
First Posted : February 11, 2015
Results First Posted : March 28, 2017
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Injury of Upper Extremity Other: Diary Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Keeping a Personal Recovery Diary on Upper Extremity Disability
Actual Study Start Date : January 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

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.
Other: Diary
Subject keeps diary of recovery

No Intervention: No Diary
Control Group



Primary Outcome Measures :
  1. Upper Extremity Disability Measured by PROMIS Upper Extremity [ Time Frame: 8 weeks ]
    Upper Extremity Disability measured by PROMIS Upper Extremity


Secondary Outcome Measures :
  1. Avoidance of Painful Activities Measured by PROMIS Pain Interference [ Time Frame: 8 weeks ]
    Avoidance of painful activities measured by PROMIS Pain Interference

  2. Symptoms of Depression Measured by PROMIS Depression [ Time Frame: 8 weeks ]
    Symptoms of depression measured by PROMIS Depression



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361580


Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: David Ring, MD PhD Massachusetts General Hospital

Responsible Party: David C. Ring, MD, Chief of Hand and Upper Extremity Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02361580     History of Changes
Other Study ID Numbers: 2014P002781
First Posted: February 11, 2015    Key Record Dates
Results First Posted: March 28, 2017
Last Update Posted: March 28, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Arm Injuries
Wounds and Injuries