Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Principal Investigator left the institution so the study was stopped before completing enrollment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| No Diary | No Intervention | Control Group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diary | Other | Subject keeps diary of recovery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Upper Extremity Disability Measured by PROMIS Upper Extremity | Upper Extremity Disability measured by PROMIS Upper Extremity | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Avoidance of Painful Activities Measured by PROMIS Pain Interference | Avoidance of painful activities measured by PROMIS Pain Interference | 8 weeks |
| Symptoms of Depression Measured by PROMIS Depression |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Ring, MD PhD | Massachusetts General Hospital | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. Diary: Subject keeps diary of recovery |
| FG001 | No Diary | Control Group |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. Diary: Subject keeps diary of recovery |
| BG001 | No Diary |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Upper Extremity Disability Measured by PROMIS Upper Extremity | Upper Extremity Disability measured by PROMIS Upper Extremity | All of the subjects were lost to follow up in both groups. | Posted | 8 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Diary: Subject keeps diary of recovery |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Taylor Pong, Research Coordinator | Massachusetts Generla Hospital | tpong1@partners.org |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Symptoms of depression measured by PROMIS Depression
| 8 weeks |
Control Group |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | Avoidance of Painful Activities Measured by PROMIS Pain Interference | Avoidance of painful activities measured by PROMIS Pain Interference | All of the subjects were lost to follow up. | Posted | 8 weeks |
|
|
| Secondary | Symptoms of Depression Measured by PROMIS Depression | Symptoms of depression measured by PROMIS Depression | All of the subjects were lost to follow up. | Posted | 8 weeks |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | No Diary | Control Group | 0 | 3 | 0 | 3 | 0 | 3 |
Not provided
Not provided
Not provided