NCT02361580

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 28, 2017

Completed
Last Updated

March 28, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

February 6, 2015

Results QC Date

February 8, 2017

Last Update Submit

February 8, 2017

Conditions

Acute Injury of Upper Extremity

Outcome Measures

Primary Outcomes (1)

  • Upper Extremity Disability Measured by PROMIS Upper Extremity

    Upper Extremity Disability measured by PROMIS Upper Extremity

    8 weeks

Secondary Outcomes (2)

  • Avoidance of Painful Activities Measured by PROMIS Pain Interference

    8 weeks

  • Symptoms of Depression Measured by PROMIS Depression

    8 weeks

Study Arms (2)

Diary

EXPERIMENTAL

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

No Diary

NO INTERVENTION

Control Group

Interventions

DiaryOTHER

Subject keeps diary of recovery

Diary

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Results Point of Contact

Title
Taylor Pong, Research Coordinator
Organization
Massachusetts Generla Hospital
tpong1@partners.org

Study Officials

  • David Ring, MD PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Hand and Upper Extremity Service

Study Record Dates

First Submitted

February 6, 2015

First Posted

February 11, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 28, 2017

Results First Posted

March 28, 2017

Record last verified: 2017-02