Trial Outcomes & Findings for Scleroderma Patient-centered Intervention Network (SPIN) Hand Program Feasibility Study (NCT NCT03092024)
NCT ID: NCT03092024
Last Updated: 2021-07-28
Results Overview
Measure: count of eligible patients
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
baseline
Results posted on
2021-07-28
Participant Flow
Assessment of trial eligibility occurred during participants' regular online SPIN Cohort assessments. Enrollment in the feasibility trial started on June 1, 2017 and was completed on June 18, 2017 when 40 eligible SPIN Cohort participants were randomized. Of these, 24 (60%) were allocated to the SPIN-HAND arm, and 16 (40%) to the usual care arm.
Participant milestones
| Measure |
SPIN-HAND Program
SPIN-HAND program: The internet-based SPIN-HAND program consists of 4 modules (1) Thumb Flexibility and Strength (3 exercises); (2) Finger Bending (3 exercises); (3) Finger Extension (3 exercises); and (4) Wrist Flexibility and Strength (2 exercises). The program includes sections on developing a personalized program, goal-setting strategies and examples, progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with hand disability and hand exercises. Instructional videos demonstrate and explain how to perform each exercise properly with pictures to illustrate common mistakes. Separate versions of each exercise are available for patients with mild/moderate and more severe hand involvement.
|
Not Offered the SPIN-HAND Program
Treatment as usual
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
16
|
|
Overall Study
COMPLETED
|
24
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Please note that there is some missing data on some disease characteristics for some participants
Baseline characteristics by cohort
| Measure |
SPIN-HAND Program
n=24 Participants
SPIN-HAND program: The internet-based SPIN-HAND program consists of 4 modules (1) Thumb Flexibility and Strength (3 exercises); (2) Finger Bending (3 exercises); (3) Finger Extension (3 exercises); and (4) Wrist Flexibility and Strength (2 exercises). The program includes sections on developing a personalized program, goal-setting strategies and examples, progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with hand disability and hand exercises. Instructional videos demonstrate and explain how to perform each exercise properly with pictures to illustrate common mistakes. Separate versions of each exercise are available for patients with mild/moderate and more severe hand involvement.
|
Not Offered the SPIN-HAND Program
n=16 Participants
Treatment as usual
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 13.5 • n=24 Participants
|
58.7 years
STANDARD_DEVIATION 16.8 • n=16 Participants
|
57.8 years
STANDARD_DEVIATION 14.7 • n=40 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=24 Participants
|
15 Participants
n=16 Participants
|
36 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=24 Participants
|
1 Participants
n=16 Participants
|
4 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
22 Participants
n=24 Participants
|
12 Participants
n=16 Participants
|
34 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=24 Participants
|
2 Participants
n=16 Participants
|
3 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=24 Participants
|
2 Participants
n=16 Participants
|
3 Participants
n=40 Participants
|
|
Education
|
15.0 years
STANDARD_DEVIATION 3.2 • n=24 Participants
|
15.2 years
STANDARD_DEVIATION 3.1 • n=16 Participants
|
15.1 years
STANDARD_DEVIATION 3.1 • n=40 Participants
|
|
Married or living as married
|
17 Participants
n=24 Participants
|
10 Participants
n=16 Participants
|
27 Participants
n=40 Participants
|
|
Country
Canada
|
8 Participants
n=24 Participants
|
4 Participants
n=16 Participants
|
12 Participants
n=40 Participants
|
|
Country
United States
|
9 Participants
n=24 Participants
|
7 Participants
n=16 Participants
|
16 Participants
n=40 Participants
|
|
Country
United Kingdom
|
7 Participants
n=24 Participants
|
5 Participants
n=16 Participants
|
12 Participants
n=40 Participants
|
|
Time since onset first non-Raynaud's symptom or sign
|
11.8 years
STANDARD_DEVIATION 7.0 • n=24 Participants • Please note that there is some missing data on some disease characteristics for some participants
|
11.6 years
STANDARD_DEVIATION 9.5 • n=14 Participants • Please note that there is some missing data on some disease characteristics for some participants
|
11.7 years
STANDARD_DEVIATION 7.9 • n=38 Participants • Please note that there is some missing data on some disease characteristics for some participants
|
|
Time since onset Raynaud's
|
14.6 years
STANDARD_DEVIATION 11.2 • n=23 Participants • Please note that there is data missing on some of the disease characteristics for some participants.
|
15.7 years
STANDARD_DEVIATION 13.6 • n=14 Participants • Please note that there is data missing on some of the disease characteristics for some participants.
|
15.0 years
STANDARD_DEVIATION 12.0 • n=37 Participants • Please note that there is data missing on some of the disease characteristics for some participants.
|
|
Time since diagnosis
|
10.0 years
STANDARD_DEVIATION 6.2 • n=24 Participants • Please note that there is data missing on some of the disease characteristics for some participants.
|
10.1 years
STANDARD_DEVIATION 8.3 • n=15 Participants • Please note that there is data missing on some of the disease characteristics for some participants.
|
10.1 years
STANDARD_DEVIATION 7.0 • n=39 Participants • Please note that there is data missing on some of the disease characteristics for some participants.
|
|
Diffuse disease subtype
|
11 Participants
n=24 Participants
|
8 Participants
n=16 Participants
|
19 Participants
n=40 Participants
|
|
Modified Rodnan Skin Score
|
9.7 scores on a scale
STANDARD_DEVIATION 10.8 • n=20 Participants • Please note that there is data missing on some of the disease characteristics for some participants.
|
17.4 scores on a scale
STANDARD_DEVIATION 10.8 • n=11 Participants • Please note that there is data missing on some of the disease characteristics for some participants.
|
12.4 scores on a scale
STANDARD_DEVIATION 11.2 • n=31 Participants • Please note that there is data missing on some of the disease characteristics for some participants.
|
|
Small joints contractures
|
6 Participants
n=24 Participants
|
7 Participants
n=16 Participants
|
13 Participants
n=40 Participants
|
|
Large joint contractures
|
4 Participants
n=24 Participants
|
4 Participants
n=16 Participants
|
8 Participants
n=40 Participants
|
|
Tendon friction rubs
|
8 Participants
n=23 Participants • Please note that there is data missing on some of the disease characteristics for some participants.
|
4 Participants
n=11 Participants • Please note that there is data missing on some of the disease characteristics for some participants.
|
12 Participants
n=34 Participants • Please note that there is data missing on some of the disease characteristics for some participants.
|
PRIMARY outcome
Timeframe: baselinePopulation: Enrollment in the feasibility trial started on June 1, 2017 and was completed on June 18, 2017 when 40 eligible SPIN Cohort participants were randomized. Of these, 24 (60%) were allocated to the SPIN-HAND arm, and 16 (40%) to the usual care arm.
Measure: count of eligible patients
Outcome measures
| Measure |
SPIN-HAND Program
n=24 Participants
SPIN-HAND program: The internet-based SPIN-HAND program consists of 4 modules (1) Thumb Flexibility and Strength (3 exercises); (2) Finger Bending (3 exercises); (3) Finger Extension (3 exercises); and (4) Wrist Flexibility and Strength (2 exercises). The program includes sections on developing a personalized program, goal-setting strategies and examples, progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with hand disability and hand exercises. Instructional videos demonstrate and explain how to perform each exercise properly with pictures to illustrate common mistakes. Separate versions of each exercise are available for patients with mild/moderate and more severe hand involvement.
|
Not Offered the SPIN-HAND Program
n=16 Participants
Treatment as usual
|
|---|---|---|
|
Eligibility: Number of Patients in the SPIN Cohort Who Meet the Cut-off Thresholds for Eligibility
|
24 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: BaselineMeasure: count of consenting patients Participants randomized to be offered the intervention received an automated email invitation including a link to the SPIN-HAND Program site and the consent form for the intervention. Participants who were randomized to care as usual were not notified that they had not been offered the intervention and completed their regular SPIN Cohort assessments. Thus, participants who were offered the intervention were not blind to their status, whereas participants assigned to usual care were blind to their participation in the trial and to their assignment to usual care.
Outcome measures
| Measure |
SPIN-HAND Program
n=24 Participants
SPIN-HAND program: The internet-based SPIN-HAND program consists of 4 modules (1) Thumb Flexibility and Strength (3 exercises); (2) Finger Bending (3 exercises); (3) Finger Extension (3 exercises); and (4) Wrist Flexibility and Strength (2 exercises). The program includes sections on developing a personalized program, goal-setting strategies and examples, progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with hand disability and hand exercises. Instructional videos demonstrate and explain how to perform each exercise properly with pictures to illustrate common mistakes. Separate versions of each exercise are available for patients with mild/moderate and more severe hand involvement.
|
Not Offered the SPIN-HAND Program
n=16 Participants
Treatment as usual
|
|---|---|---|
|
Enrolment: Percentage of Patients Who Consent to Participation
|
15 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Of the 15 intervention arm participants, 6 participated in the interview. Of the 9 participants who were not interviewed, 1 withdrew a few days after consenting to the feasibility trial, 3 were unreachable at 3-month post-randomization (3 contact attempts), 5 declined (2 participants indicated that they did not use the program enough, 2 declined due to health problems, 1 mentioned exercise was not a priority). None of the participants randomized to usual care participated in these interviews.
At 3-months post-randomization, qualitative semi-structured interviews were conducted with participants in the intervention arm to assess user acceptability and satisfaction. The interview, consisting of 29 questions, was guided by items of the Patient Education Materials Assessment Tool for Audiovisual Materials and addressed topics related to usability, understandability, organization, and clarity. During these interviews, participants were asked to give the SPIN-HAND program a grade ranging from 0-10, 0 being the worst and 10 being the best possible score. In this table, we report the overall mean grade reported by the intervention arm participants who agreed to be interviewed post-trial.
Outcome measures
| Measure |
SPIN-HAND Program
n=6 Participants
SPIN-HAND program: The internet-based SPIN-HAND program consists of 4 modules (1) Thumb Flexibility and Strength (3 exercises); (2) Finger Bending (3 exercises); (3) Finger Extension (3 exercises); and (4) Wrist Flexibility and Strength (2 exercises). The program includes sections on developing a personalized program, goal-setting strategies and examples, progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with hand disability and hand exercises. Instructional videos demonstrate and explain how to perform each exercise properly with pictures to illustrate common mistakes. Separate versions of each exercise are available for patients with mild/moderate and more severe hand involvement.
|
Not Offered the SPIN-HAND Program
Treatment as usual
|
|---|---|---|
|
Participant Grade on Usability of the SPIN-HAND Program Based on Post-trial Patient Interviews
|
8.5 Overall mean grade for SPIN-HAND program
Standard Deviation 1.5
|
—
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: None of the participants randomized to usual care logged into the SPIN-HAND program.
Usage of the online SPIN-HAND program was measured based on usage log data, notably the number of participants who logged into the program once, twice or more than two times. Program usage was also measured based on the number of participants who accessed different parts of the online SPIN-HAND program including: the introduction videos, the website tour, the page explaining the level of hand involvement to identify the exercises most relevant to them, the four available modules of the online SPIN-HAND program, as well as the goal-setting feature.
Outcome measures
| Measure |
SPIN-HAND Program
n=15 Participants
SPIN-HAND program: The internet-based SPIN-HAND program consists of 4 modules (1) Thumb Flexibility and Strength (3 exercises); (2) Finger Bending (3 exercises); (3) Finger Extension (3 exercises); and (4) Wrist Flexibility and Strength (2 exercises). The program includes sections on developing a personalized program, goal-setting strategies and examples, progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with hand disability and hand exercises. Instructional videos demonstrate and explain how to perform each exercise properly with pictures to illustrate common mistakes. Separate versions of each exercise are available for patients with mild/moderate and more severe hand involvement.
|
Not Offered the SPIN-HAND Program
Treatment as usual
|
|---|---|---|
|
Intervention Use: Number of Logins to the SPIN-HAND Program and Number of Participants Who Accessed SPIN-HAND Program Online Features
Logged in 1 time
|
7 Participants
|
—
|
|
Intervention Use: Number of Logins to the SPIN-HAND Program and Number of Participants Who Accessed SPIN-HAND Program Online Features
Logged in 2 times
|
3 Participants
|
—
|
|
Intervention Use: Number of Logins to the SPIN-HAND Program and Number of Participants Who Accessed SPIN-HAND Program Online Features
Logged in more than 2 times
|
5 Participants
|
—
|
|
Intervention Use: Number of Logins to the SPIN-HAND Program and Number of Participants Who Accessed SPIN-HAND Program Online Features
Number of participants who watched introduction videos
|
11 Participants
|
—
|
|
Intervention Use: Number of Logins to the SPIN-HAND Program and Number of Participants Who Accessed SPIN-HAND Program Online Features
Number of participants who used the website tour
|
6 Participants
|
—
|
|
Intervention Use: Number of Logins to the SPIN-HAND Program and Number of Participants Who Accessed SPIN-HAND Program Online Features
Number of participants who accessed page to identify relevant exercises
|
10 Participants
|
—
|
|
Intervention Use: Number of Logins to the SPIN-HAND Program and Number of Participants Who Accessed SPIN-HAND Program Online Features
Number of participants who did not access any module
|
6 Participants
|
—
|
|
Intervention Use: Number of Logins to the SPIN-HAND Program and Number of Participants Who Accessed SPIN-HAND Program Online Features
Number of participants who accessed 1 of the 4 modules
|
4 Participants
|
—
|
|
Intervention Use: Number of Logins to the SPIN-HAND Program and Number of Participants Who Accessed SPIN-HAND Program Online Features
Number of participants who accessed 3-4 modules
|
2 Participants
|
—
|
|
Intervention Use: Number of Logins to the SPIN-HAND Program and Number of Participants Who Accessed SPIN-HAND Program Online Features
Number of participants who used the goal-setting feature
|
4 Participants
|
—
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: None of the participants randomized to usual care logged into the SPIN-HAND program
Here we report our success in collecting participant usage log data. This is reported as the percentage of the usage log data that was successfully collected.
Outcome measures
| Measure |
SPIN-HAND Program
n=15 Participants
SPIN-HAND program: The internet-based SPIN-HAND program consists of 4 modules (1) Thumb Flexibility and Strength (3 exercises); (2) Finger Bending (3 exercises); (3) Finger Extension (3 exercises); and (4) Wrist Flexibility and Strength (2 exercises). The program includes sections on developing a personalized program, goal-setting strategies and examples, progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with hand disability and hand exercises. Instructional videos demonstrate and explain how to perform each exercise properly with pictures to illustrate common mistakes. Separate versions of each exercise are available for patients with mild/moderate and more severe hand involvement.
|
Not Offered the SPIN-HAND Program
Treatment as usual
|
|---|---|---|
|
Usage Log Data: Completeness of the Automatic Usage Log Data Values Collected
|
100 Percent completeness of usage log data
|
—
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: None of the participants randomized to usual care logged into the SPIN-HAND program
We report our percentage success in linking data coming from the SPIN Cohort and SPIN-HAND platforms.
Outcome measures
| Measure |
SPIN-HAND Program
n=15 Participants
SPIN-HAND program: The internet-based SPIN-HAND program consists of 4 modules (1) Thumb Flexibility and Strength (3 exercises); (2) Finger Bending (3 exercises); (3) Finger Extension (3 exercises); and (4) Wrist Flexibility and Strength (2 exercises). The program includes sections on developing a personalized program, goal-setting strategies and examples, progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with hand disability and hand exercises. Instructional videos demonstrate and explain how to perform each exercise properly with pictures to illustrate common mistakes. Separate versions of each exercise are available for patients with mild/moderate and more severe hand involvement.
|
Not Offered the SPIN-HAND Program
Treatment as usual
|
|---|---|---|
|
Usage Log Data: Linking of Data From the SPIN Cohort and SPIN-HAND Platforms.
|
100 % success linking participant data
|
—
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 6 of the 15 intervention arm participants agreed to be interviewed post-trial. Participants randomized to usual care were not interviewed.
Measure: count of technological problems reported SPIN personnel reported no issues with the technological performance of the online SPIN-HAND program. As part of the user feedback interviews, participants of the SPIN-HAND program were asked whether they experienced technological difficulties during the intervention. Here, we report the number of intervention-arm participants who reported technological issues, during these post-trial interviews. In cases of technological difficulty experienced by participants, technological assistance was provided by the SPIN team, and the issues were resolved.
Outcome measures
| Measure |
SPIN-HAND Program
n=6 Participants
SPIN-HAND program: The internet-based SPIN-HAND program consists of 4 modules (1) Thumb Flexibility and Strength (3 exercises); (2) Finger Bending (3 exercises); (3) Finger Extension (3 exercises); and (4) Wrist Flexibility and Strength (2 exercises). The program includes sections on developing a personalized program, goal-setting strategies and examples, progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with hand disability and hand exercises. Instructional videos demonstrate and explain how to perform each exercise properly with pictures to illustrate common mistakes. Separate versions of each exercise are available for patients with mild/moderate and more severe hand involvement.
|
Not Offered the SPIN-HAND Program
Treatment as usual
|
|---|---|---|
|
Count of Participants Who Reported Technological Problems During Post-trial Patient Interviews
Participants who reported no technology issues
|
4 Participants
|
0 Participants
|
|
Count of Participants Who Reported Technological Problems During Post-trial Patient Interviews
Participants who reported internet connectivity issues
|
1 Participants
|
—
|
|
Count of Participants Who Reported Technological Problems During Post-trial Patient Interviews
Participants who reported login issue (resolved by SPIN team)
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Of the 40 participants, 26 (65%) completed their 3-months follow-up assessments, including 14 in the intervention arm (58%) and 12 in the control arm (75%).
The Cochin Hand Function Scale (CHFS) measures functional ability of the hand among patients with rheumatic diseases. The 18-item CHFS measures ability to perform daily hand-related activities (e.g., kitchen, dressing oneself, hygiene, writing/typing). Items are scored on a 0-5 Likert scale (0=without difficulty; 5=impossible). Higher scores indicate less functionality. The total score is obtained by adding the scores of all items (range 0-90).
Outcome measures
| Measure |
SPIN-HAND Program
n=24 Participants
SPIN-HAND program: The internet-based SPIN-HAND program consists of 4 modules (1) Thumb Flexibility and Strength (3 exercises); (2) Finger Bending (3 exercises); (3) Finger Extension (3 exercises); and (4) Wrist Flexibility and Strength (2 exercises). The program includes sections on developing a personalized program, goal-setting strategies and examples, progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with hand disability and hand exercises. Instructional videos demonstrate and explain how to perform each exercise properly with pictures to illustrate common mistakes. Separate versions of each exercise are available for patients with mild/moderate and more severe hand involvement.
|
Not Offered the SPIN-HAND Program
n=16 Participants
Treatment as usual
|
|---|---|---|
|
The Cochin Hand Function Scale (CHFS)
Baseline
|
21.9 units on a scale
Standard Deviation 15.5
|
21.1 units on a scale
Standard Deviation 16.1
|
|
The Cochin Hand Function Scale (CHFS)
Month 3
|
22.0 units on a scale
Standard Deviation 15.5
|
20.9 units on a scale
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Of the 40 participants, 26 (65%) completed their 3-months follow-up assessments, including 14 in the intervention arm (58%) and 12 in the control arm (75%).
The EuroQol Group 5 Dimension 5 Level (EQ-5D-5L) is standardized questionnaire measuring 5 dimensions related to health related quality of life, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, items are rated from 1 (no problems) to 5 (extreme problems). Here we report the number of intervention arm and control arm participants who gave scores ranging 1-5 for the different dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), at baseline and at 3-months post randomization.
Outcome measures
| Measure |
SPIN-HAND Program
n=24 Participants
SPIN-HAND program: The internet-based SPIN-HAND program consists of 4 modules (1) Thumb Flexibility and Strength (3 exercises); (2) Finger Bending (3 exercises); (3) Finger Extension (3 exercises); and (4) Wrist Flexibility and Strength (2 exercises). The program includes sections on developing a personalized program, goal-setting strategies and examples, progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with hand disability and hand exercises. Instructional videos demonstrate and explain how to perform each exercise properly with pictures to illustrate common mistakes. Separate versions of each exercise are available for patients with mild/moderate and more severe hand involvement.
|
Not Offered the SPIN-HAND Program
n=16 Participants
Treatment as usual
|
|---|---|---|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Mobility - Baseline · Level 1
|
7 Participants
|
5 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Mobility - Baseline · Level 2
|
8 Participants
|
6 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Mobility - Baseline · Level 3
|
8 Participants
|
3 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Mobility - Baseline · Level 4
|
1 Participants
|
2 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Mobility - Baseline · Level 5
|
0 Participants
|
0 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Mobility - Month 3 · Level 1
|
5 Participants
|
7 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Mobility - Month 3 · Level 2
|
7 Participants
|
1 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Mobility - Month 3 · Level 3
|
0 Participants
|
2 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Mobility - Month 3 · Level 4
|
2 Participants
|
2 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Mobility - Month 3 · Level 5
|
0 Participants
|
0 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Self care - Baseline · Level 1
|
10 Participants
|
7 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Self care - Baseline · Level 2
|
9 Participants
|
7 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Self care - Baseline · Level 3
|
4 Participants
|
1 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Self care - Baseline · Level 4
|
0 Participants
|
1 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Self care - Baseline · Level 5
|
1 Participants
|
0 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Self care - Month 3 · Level 1
|
8 Participants
|
4 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Self care - Month 3 · Level 2
|
3 Participants
|
7 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Self care - Month 3 · Level 3
|
2 Participants
|
1 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Self care - Month 3 · Level 4
|
1 Participants
|
0 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Self care - Month 3 · Level 5
|
0 Participants
|
0 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Usual activity - Baseline · Level 1
|
6 Participants
|
0 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Usual activity - Baseline · Level 2
|
8 Participants
|
8 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Usual activity - Baseline · Level 3
|
8 Participants
|
5 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Usual activity - Baseline · Level 4
|
2 Participants
|
3 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Usual activity - Baseline · Level 5
|
0 Participants
|
0 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Usual activity - Month 3 · Level 1
|
4 Participants
|
2 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Usual activity - Month 3 · Level 2
|
6 Participants
|
5 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Usual activity - Month 3 · Level 3
|
2 Participants
|
4 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Usual activity - Month 3 · Level 4
|
2 Participants
|
1 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Usual activity - Month 3 · Level 5
|
0 Participants
|
0 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Pain/Discomfort - Baseline · Level 1
|
2 Participants
|
1 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Pain/Discomfort - Baseline · Level 2
|
10 Participants
|
4 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Pain/Discomfort - Baseline · Level 3
|
9 Participants
|
8 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Pain/Discomfort - Baseline · Level 4
|
3 Participants
|
3 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Pain/Discomfort - Baseline · Level 5
|
0 Participants
|
0 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Pain/Discomfort - Month 3 · Level 1
|
1 Participants
|
0 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Pain/Discomfort - Month 3 · Level 2
|
5 Participants
|
2 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Pain/Discomfort - Month 3 · Level 3
|
5 Participants
|
10 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Pain/Discomfort - Month 3 · Level 4
|
3 Participants
|
0 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Pain/Discomfort - Month 3 · Level 5
|
0 Participants
|
0 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Anxiety/Depression - Baseline · Level 1
|
8 Participants
|
5 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Anxiety/Depression - Baseline · Level 2
|
11 Participants
|
8 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Anxiety/Depression - Baseline · Level 3
|
3 Participants
|
3 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Anxiety/Depression - Baseline · Level 4
|
2 Participants
|
0 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Anxiety/Depression - Baseline · Level 5
|
0 Participants
|
0 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Anxiety/Depression - Month 3 · Level 1
|
11 Participants
|
6 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Anxiety/Depression - Month 3 · Level 2
|
2 Participants
|
4 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Anxiety/Depression - Month 3 · Level 3
|
1 Participants
|
1 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Anxiety/Depression - Month 3 · Level 4
|
0 Participants
|
1 Participants
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Anxiety/Depression - Month 3 · Level 5
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Of the 40 participants, 26 (65%) completed their 3-months follow-up assessments, including 14 in the intervention arm (58%) and 12 in the control arm (75%).
As part of the EQ-5D-5L questionnaire, a Visual Analogue Scale (VAS) records the patient's self-rated health on a scale from 0-100 where the endpoints are labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0). Here we report the mean (and standard deviations) self-reported patient health VAS scores of intervention arm participants and control arm participants (i.e. usual care), at baseline and at 3-months post-randomization.
Outcome measures
| Measure |
SPIN-HAND Program
n=24 Participants
SPIN-HAND program: The internet-based SPIN-HAND program consists of 4 modules (1) Thumb Flexibility and Strength (3 exercises); (2) Finger Bending (3 exercises); (3) Finger Extension (3 exercises); and (4) Wrist Flexibility and Strength (2 exercises). The program includes sections on developing a personalized program, goal-setting strategies and examples, progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with hand disability and hand exercises. Instructional videos demonstrate and explain how to perform each exercise properly with pictures to illustrate common mistakes. Separate versions of each exercise are available for patients with mild/moderate and more severe hand involvement.
|
Not Offered the SPIN-HAND Program
n=16 Participants
Treatment as usual
|
|---|---|---|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Visual Analogue Scale (VAS) Scores for Patient Self-rated Health
Baseline
|
64.9 score on a scale
Standard Deviation 19.7
|
56.8 score on a scale
Standard Deviation 15.9
|
|
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Visual Analogue Scale (VAS) Scores for Patient Self-rated Health
Month 3
|
66.9 score on a scale
Standard Deviation 19.8
|
54.9 score on a scale
Standard Deviation 13.1
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Of the 40 participants, 26 (65%) completed their 3-months follow-up assessments, including 14 in the intervention arm (58%) and 12 in the control arm (75%).
Measures 8 domains of health status with 4 items for each of 7 domains (physical function, anxiety, depression, fatigue, sleep disturbance, social roles and activities, pain interference) plus a single item for pain intensity. Items are scored on a 5-point scale (range 1-5), with different response options for different domains, and the single pain intensity item is measured on an 11-point rating scale. Higher scores represent more of the domain being measured; that is, better physical function and ability to participate in social roles and activities, but higher levels of anxiety, depression, fatigue, sleep disturbance, pain interference, and pain intensity. Total raw scores are obtained by summing item scores for each domain, which are converted into T-scores standardized from the general US population (mean=50, SD=10). Here, we report the pre- and post-intervention total scores for PROMIS-29 domains.
Outcome measures
| Measure |
SPIN-HAND Program
n=24 Participants
SPIN-HAND program: The internet-based SPIN-HAND program consists of 4 modules (1) Thumb Flexibility and Strength (3 exercises); (2) Finger Bending (3 exercises); (3) Finger Extension (3 exercises); and (4) Wrist Flexibility and Strength (2 exercises). The program includes sections on developing a personalized program, goal-setting strategies and examples, progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with hand disability and hand exercises. Instructional videos demonstrate and explain how to perform each exercise properly with pictures to illustrate common mistakes. Separate versions of each exercise are available for patients with mild/moderate and more severe hand involvement.
|
Not Offered the SPIN-HAND Program
n=16 Participants
Treatment as usual
|
|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0
PROMIS-29 Physical Function Domain- Month 3
|
42.2 T-score
Standard Deviation 8.6
|
41.1 T-score
Standard Deviation 6.6
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0
PROMIS-29 Anxiety Domain- Month 3
|
48.7 T-score
Standard Deviation 8.2
|
53.2 T-score
Standard Deviation 9.6
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0
PROMIS-29 Depression Domain- Baseline
|
51.8 T-score
Standard Deviation 10.1
|
53.7 T-score
Standard Deviation 9.9
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0
PROMIS-29 Depression Domain- Month 3
|
47.4 T-score
Standard Deviation 8.0
|
51.6 T-score
Standard Deviation 9.8
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0
PROMIS-29 Fatigue Domain- Baseline
|
58.3 T-score
Standard Deviation 12.0
|
59.3 T-score
Standard Deviation 7.4
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0
PROMIS-29 Fatigue Domain- Month 3
|
55.7 T-score
Standard Deviation 10.7
|
58.7 T-score
Standard Deviation 8.9
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0
PROMIS-29 Sleep Domain- Baseline
|
54.3 T-score
Standard Deviation 8.7
|
53.6 T-score
Standard Deviation 9.6
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0
PROMIS-29 Sleep Domain- Month 3
|
50.4 T-score
Standard Deviation 6.7
|
54.3 T-score
Standard Deviation 6.1
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0
PROMIS-29 Social Roles Domain- Baseline
|
46.0 T-score
Standard Deviation 8.7
|
42.3 T-score
Standard Deviation 7.8
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0
PROMIS-29 Social Roles Domain- Month 3
|
49.5 T-score
Standard Deviation 10.0
|
40.7 T-score
Standard Deviation 8.2
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0
PROMIS-29 Pain Interference Domain- Baseline
|
57.7 T-score
Standard Deviation 9.9
|
61.7 T-score
Standard Deviation 5.9
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0
PROMIS-29 Pain Interference Domain- Month 3
|
56.1 T-score
Standard Deviation 7.8
|
60.6 T-score
Standard Deviation 6.7
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0
PROMIS-29 Pain Intensity Domain- Baseline
|
4.7 T-score
Standard Deviation 2.8
|
5.9 T-score
Standard Deviation 1.9
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0
PROMIS-29 Pain Intensity Domain- Month 3
|
4.9 T-score
Standard Deviation 2.7
|
5.3 T-score
Standard Deviation 1.9
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0
PROMIS-29 Anxiety Domain- Baseline
|
53.8 T-score
Standard Deviation 10.5
|
56.7 T-score
Standard Deviation 9.9
|
|
Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0
PROMIS-29 Physical Function Domain- Baseline
|
40.7 T-score
Standard Deviation 8.9
|
39.4 T-score
Standard Deviation 6.5
|
Adverse Events
SPIN-HAND Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Not Offered the SPIN-HAND Program
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place