Impact of Keeping a Personal Recovery Diary on Upper Extremity Disability

Acute Injury of Upper Extremity Clinical Trial

Official title:

Impact of Keeping a Personal Recovery Diary on Upper Extremity Disability

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02361580
• Other study ID #: 2014P002781
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 6, 2015
• Last updated: February 10, 2015
• Start date: January 2015

Study information

• Verified date: February 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 128
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Injury of Upper Extremity
• Arm Injuries

Intervention

Other:
• Diary
Subject keeps diary of recovery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper Extremity Disability measured by PROMIS Upper Extremity	Upper Extremity Disability measured by PROMIS Upper Extremity	8 weeks	No
Secondary	Avoidance of painful activities measured by PROMIS Pain Interference	Avoidance of painful activities measured by PROMIS Pain Interference	8 weeks	No
Secondary	Symptoms of Depression measured by PROMIS Depression	Symptoms of depression measured by PROMIS Depression	8 weeks	No