Acute Injury of Upper ExtremityNCT02361580
Impact of Keeping a Personal Recovery Diary on Upper Extremity Disability
A study testing Diary in people with Acute Injury of Upper Extremity, run by Massachusetts General Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Injury of Upper Extremity
- What is being tested?
- Diary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant women
About this study
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.
Read the 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
- Conditions
- Acute Injury of Upper Extremity
- Being tested
- Diary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiaryOther
Subject keeps diary of recovery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Diary |
| No Diary | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremity Disability Measured by PROMIS Upper Extremity
Upper Extremity Disability measured by PROMIS Upper Extremity
Measured: 8 weeks
Secondary outcomes (2)
Avoidance of Painful Activities Measured by PROMIS Pain Interference
Avoidance of painful activities measured by PROMIS Pain Interference
Measured: 8 weeks
Symptoms of Depression Measured by PROMIS Depression
Symptoms of depression measured by PROMIS Depression
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: The Principal Investigator left the institution so the study was stopped before completing enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Injury of Upper ExtremityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David C. Ring, MD, Massachusetts General Hospital
- Investigators
- David Ring, MD PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361580
- Sponsor's protocol ID
- 2014P002781
- Status last verified
- Feb 2017
- First submitted
- 6 Feb 2015
- Last updated
- 28 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Keeping a Personal Recovery Diary on Upper Extremity Disability
- ClinicalTrials.gov ID
- NCT02361580
- Acronym / sponsor ID
- 2014P002781
- Conditions
- Acute Injury of Upper Extremity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Principal Investigator left the institution so the study was stopped before completing enrollment.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 11 Feb 2015 (estimated)
- Results
- Posted 28 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diary | Experimental | Other: DiarySubjects 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. |
| No Diary | No intervention | –Control Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiarySubject keeps diary of recovery | Other | Diary |
Primary outcome
Upper Extremity Disability Measured by PROMIS Upper Extremity
Time frame: 8 weeks
Upper Extremity Disability measured by PROMIS Upper Extremity
2 secondary outcomes
Avoidance of Painful Activities Measured by PROMIS Pain Interference
Time frame: 8 weeks
Symptoms of Depression Measured by PROMIS Depression
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ring, MD PhD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Diary in people with Acute Injury of Upper Extremity, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Extremity Disability Measured by PROMIS Upper Extremity (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.