Trial Outcomes & Findings for Impact of Keeping a Personal Recovery Diary on Upper Extremity Disability (NCT NCT02361580)

Results Overview

Upper Extremity Disability measured by PROMIS Upper Extremity

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

8 weeks

Results posted on

2017-03-28

Participant Flow

Participant milestones

Participant milestones
Measure	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	No Diary Control Group
Overall Study STARTED	6	3
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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	No Diary Control Group
Overall Study Lost to Follow-up	6	3

Baseline Characteristics

Impact of Keeping a Personal Recovery Diary on Upper Extremity Disability

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diary n=6 Participants 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	No Diary n=3 Participants Control Group	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=99 Participants	2 Participants n=107 Participants	7 Participants n=206 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Age, Continuous	51 years STANDARD_DEVIATION 19 • n=99 Participants	54 years STANDARD_DEVIATION 10 • n=107 Participants	52 years STANDARD_DEVIATION 16 • n=206 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants
Sex: Female, Male Male	3 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants
Region of Enrollment United States	6 participants n=99 Participants	3 participants n=107 Participants	9 participants n=206 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: All of the subjects were lost to follow up in both groups.

Upper Extremity Disability measured by PROMIS Upper Extremity

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Population: All of the subjects were lost to follow up.

Avoidance of painful activities measured by PROMIS Pain Interference

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Population: All of the subjects were lost to follow up.

Symptoms of depression measured by PROMIS Depression

Outcome measures

Outcome data not reported

Adverse Events

Diary

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Diary

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Taylor Pong, Research Coordinator

Massachusetts Generla Hospital

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place