Trial Outcomes & Findings for The Scleroderma Patient-centered Intervention Network (SPIN) Support Group Leader Education Program Feasibility Trial (NCT NCT03508661)

Results Overview

Participant Interviews. Participants were asked if they found the program to be useful. The number of participants who found the program materials to be useful were recorded

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

13 week

Results posted on

2020-02-12

Participant Flow

Scleroderma Canada and the Scleroderma Foundation were asked to generate a list of 12 interested scleroderma support group leaders. These leaders received an initial email invitation to join the study along with the consent form and the first 10 leaders to consent were enrolled in the study. Participants were recruited from February to March 2018.

One of the 10 participants who initially indicated that she would participate was hospitalized and was unable to take part before providing informed consent. This participant was replaced with one of the remaining interested support group leaders that were contacted prior to the start of the program. Thus, 10 participants were enrolled.

Participant milestones

Participant milestones
Measure	SPIN-SSLED Program SPIN-SSLED Program: The program includes 13 modules that will be delivered live via webinar over the course of the 3-month program. Each module will be delivered in a 60- to 90-minute session. Module topics include (1) the leader's role; (2) starting a support group; (3) structuring a support group meeting; (4) scleroderma 101; (5) successful support group culture; (6 \&7) managing support group dynamics I and II; (8) grief and crisis in scleroderma; (9) marketing and recruitment; (10) the continuity of the group; (11) supporting yourself as a leader; (12) virtual support group meetings, (13) support group leader resources. Participants will receive a workbook, be shown filmed vignettes, and will have access to an online resource center.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Scleroderma Patient-centered Intervention Network (SPIN) Support Group Leader Education Program Feasibility Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SPIN-SSLED Program n=10 Participants SPIN-SSLED Program: The program includes 13 modules that will be delivered live via webinar over the course of the 3-month program. Each module will be delivered in a 60- to 90-minute session. Module topics include (1) the leader's role; (2) starting a support group; (3) structuring a support group meeting; (4) scleroderma 101; (5) successful support group culture; (6 \&7) managing support group dynamics I and II; (8) grief and crisis in scleroderma; (9) marketing and recruitment; (10) the continuity of the group; (11) supporting yourself as a leader; (12) virtual support group meetings, (13) support group leader resources. Participants will receive a workbook, be shown filmed vignettes, and will have access to an online resource center.
Age, Continuous	57.7 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized White	10 Participants n=5 Participants
Race/Ethnicity, Customized Aboriginal	1 Participants n=5 Participants
Relationship status Married or living as married	8 Participants n=5 Participants
Relationship status Separated or divorced	2 Participants n=5 Participants
Education	17.5 years STANDARD_DEVIATION 2.7 • n=5 Participants
Occupational status Homemaker	1 Participants n=5 Participants
Occupational status Part- or full-time employment	2 Participants n=5 Participants
Occupational status Disability	3 Participants n=5 Participants
Occupational status Retired	4 Participants n=5 Participants
Scleroderma diagnosis Limited scleroderma	4 Participants n=5 Participants
Scleroderma diagnosis Diffuse scleroderma	5 Participants n=5 Participants
Scleroderma diagnosis Not diagnosed with scleroderma	1 Participants n=5 Participants
Years since diagnosis	10.9 years STANDARD_DEVIATION 7.4 • n=5 Participants
Current leader of scleroderma support group	10 Participants n=5 Participants
Years as a support group leader	3.6 years STANDARD_DEVIATION 3.7 • n=5 Participants

PRIMARY outcome

Timeframe: 13 week

Participant Interviews. Participants were asked if they found the program to be useful. The number of participants who found the program materials to be useful were recorded

Outcome measures

Outcome measures
Measure	SPIN-SSLED Program n=10 Participants SPIN-SSLED Program: The program includes 13 modules that will be delivered live via webinar over the course of the 3-month program. Each module will be delivered in a 60- to 90-minute session. Module topics include (1) the leader's role; (2) starting a support group; (3) structuring a support group meeting; (4) scleroderma 101; (5) successful support group culture; (6 \&7) managing support group dynamics I and II; (8) grief and crisis in scleroderma; (9) marketing and recruitment; (10) the continuity of the group; (11) supporting yourself as a leader; (12) virtual support group meetings, (13) support group leader resources. Participants will receive a workbook, be shown filmed vignettes, and will have access to an online resource center.
Participant Feedback on Usability of Program Materials	10 Participants

PRIMARY outcome

Timeframe: 13 weeks

Participant Interviews. Participants were asked if they encountered difficulties during the use of Go-To videoconferencing program. Number of participants who found no difficulty in using the program is reported.

Outcome measures

Outcome measures
Measure	SPIN-SSLED Program n=10 Participants SPIN-SSLED Program: The program includes 13 modules that will be delivered live via webinar over the course of the 3-month program. Each module will be delivered in a 60- to 90-minute session. Module topics include (1) the leader's role; (2) starting a support group; (3) structuring a support group meeting; (4) scleroderma 101; (5) successful support group culture; (6 \&7) managing support group dynamics I and II; (8) grief and crisis in scleroderma; (9) marketing and recruitment; (10) the continuity of the group; (11) supporting yourself as a leader; (12) virtual support group meetings, (13) support group leader resources. Participants will receive a workbook, be shown filmed vignettes, and will have access to an online resource center.
Participant Feedback on Ease of Use of the Go-To Videoconferencing Program No technical difficulties	8 Participants
Participant Feedback on Ease of Use of the Go-To Videoconferencing Program Minor difficulties	2 Participants

PRIMARY outcome

Timeframe: 13 weeks

Participant Interviews. Participants were asked to report the overall technological difficulties that they experienced using the online forum.

Outcome measures

Outcome measures
Measure	SPIN-SSLED Program n=10 Participants SPIN-SSLED Program: The program includes 13 modules that will be delivered live via webinar over the course of the 3-month program. Each module will be delivered in a 60- to 90-minute session. Module topics include (1) the leader's role; (2) starting a support group; (3) structuring a support group meeting; (4) scleroderma 101; (5) successful support group culture; (6 \&7) managing support group dynamics I and II; (8) grief and crisis in scleroderma; (9) marketing and recruitment; (10) the continuity of the group; (11) supporting yourself as a leader; (12) virtual support group meetings, (13) support group leader resources. Participants will receive a workbook, be shown filmed vignettes, and will have access to an online resource center.
Participant Feedback on Ease of Use of the Online Forum Minimal difficulties	10 Participants
Participant Feedback on Ease of Use of the Online Forum Other difficulties	0 Participants

PRIMARY outcome

Timeframe: 13 weeks

Time logs completed by research staff will be used to assess personnel requirements for the full-scale trial.

Outcome measures

Outcome measures
Measure	SPIN-SSLED Program n=10 Participants SPIN-SSLED Program: The program includes 13 modules that will be delivered live via webinar over the course of the 3-month program. Each module will be delivered in a 60- to 90-minute session. Module topics include (1) the leader's role; (2) starting a support group; (3) structuring a support group meeting; (4) scleroderma 101; (5) successful support group culture; (6 \&7) managing support group dynamics I and II; (8) grief and crisis in scleroderma; (9) marketing and recruitment; (10) the continuity of the group; (11) supporting yourself as a leader; (12) virtual support group meetings, (13) support group leader resources. Participants will receive a workbook, be shown filmed vignettes, and will have access to an online resource center.
Personnel Requirements	0 personnel required

PRIMARY outcome

Timeframe: 13 weeks

The challenges related to the management of online training group participation encountered by study personnel, including assisting participants with accessing GoToMeeting and managing Qualtrics for data collection. Time required for management of training groups could not be assigned to individual participants as sometimes the group needed support, and other times an individual did. Thus, the number presented represents the total time required.

Outcome measures

Outcome measures
Measure	SPIN-SSLED Program n=10 Participants SPIN-SSLED Program: The program includes 13 modules that will be delivered live via webinar over the course of the 3-month program. Each module will be delivered in a 60- to 90-minute session. Module topics include (1) the leader's role; (2) starting a support group; (3) structuring a support group meeting; (4) scleroderma 101; (5) successful support group culture; (6 \&7) managing support group dynamics I and II; (8) grief and crisis in scleroderma; (9) marketing and recruitment; (10) the continuity of the group; (11) supporting yourself as a leader; (12) virtual support group meetings, (13) support group leader resources. Participants will receive a workbook, be shown filmed vignettes, and will have access to an online resource center.
Duration of Management of Online Training Group Participation	2 hours

PRIMARY outcome

Timeframe: 13 weeks

Intervention fidelity will be evaluated through the observation of entire sessions for a randomly selected sample of 25% of video-recorded sessions. Raters will evaluate adherence to each session's goals and content using a checklist coding system based on a standardized format. Two raters reviewed 54 topics from 7 randomly chosen modules from both training groups to examine if the contents were adequately covered.

Outcome measures

Outcome measures
Measure	SPIN-SSLED Program n=54 Topics SPIN-SSLED Program: The program includes 13 modules that will be delivered live via webinar over the course of the 3-month program. Each module will be delivered in a 60- to 90-minute session. Module topics include (1) the leader's role; (2) starting a support group; (3) structuring a support group meeting; (4) scleroderma 101; (5) successful support group culture; (6 \&7) managing support group dynamics I and II; (8) grief and crisis in scleroderma; (9) marketing and recruitment; (10) the continuity of the group; (11) supporting yourself as a leader; (12) virtual support group meetings, (13) support group leader resources. Participants will receive a workbook, be shown filmed vignettes, and will have access to an online resource center.
Percentage of Topics Adequately Covered in the Sessions Covered topics	96 percentage
Percentage of Topics Adequately Covered in the Sessions Not covered topics	4 percentage

PRIMARY outcome

Timeframe: 13 weeks

Log of technological problems reported by staff and participants will be maintained and reported descriptively.

Outcome measures

Outcome measures
Measure	SPIN-SSLED Program n=10 Participants SPIN-SSLED Program: The program includes 13 modules that will be delivered live via webinar over the course of the 3-month program. Each module will be delivered in a 60- to 90-minute session. Module topics include (1) the leader's role; (2) starting a support group; (3) structuring a support group meeting; (4) scleroderma 101; (5) successful support group culture; (6 \&7) managing support group dynamics I and II; (8) grief and crisis in scleroderma; (9) marketing and recruitment; (10) the continuity of the group; (11) supporting yourself as a leader; (12) virtual support group meetings, (13) support group leader resources. Participants will receive a workbook, be shown filmed vignettes, and will have access to an online resource center.
Number of Participants That Reported no Technological Problems No technological problems	8 participants
Number of Participants That Reported no Technological Problems Some technological problems	2 participants

SECONDARY outcome

Timeframe: 13 weeks

The SSGLSS consists of 32 core items that assess the confidence of SSc support group leaders to carry out tasks necessary for leading a support group successfully. Items are scored on a 6-point scale ranging from Strongly Disagree to Strongly Agree (scored 0-5). Possible total scores range from 0 to 160 with higher scores indicating greater self-efficacy.

Outcome measures

Outcome measures
Measure	SPIN-SSLED Program n=10 Participants SPIN-SSLED Program: The program includes 13 modules that will be delivered live via webinar over the course of the 3-month program. Each module will be delivered in a 60- to 90-minute session. Module topics include (1) the leader's role; (2) starting a support group; (3) structuring a support group meeting; (4) scleroderma 101; (5) successful support group culture; (6 \&7) managing support group dynamics I and II; (8) grief and crisis in scleroderma; (9) marketing and recruitment; (10) the continuity of the group; (11) supporting yourself as a leader; (12) virtual support group meetings, (13) support group leader resources. Participants will receive a workbook, be shown filmed vignettes, and will have access to an online resource center.
The Scleroderma Support Group Leader Self-efficacy Scale (SSGLSS)	1.7 units on a scale Interval 0.67 to 2.72

SECONDARY outcome

Timeframe: baseline and 13 weeks

The Personal Health Questionnaire (PHQ-8) is a self-administered 8-item scale to assess depression that has been validated for use in populations with SSc. Items are rated on a 4-point Likert scale (not at all, several days, more than half the days, nearly every day). The total values range from 0 to 24, with higher scores indicating higher levels of depressive symptoms. The difference of pre- and post-trial means was calculated.

Outcome measures

Outcome measures
Measure	SPIN-SSLED Program n=10 Participants SPIN-SSLED Program: The program includes 13 modules that will be delivered live via webinar over the course of the 3-month program. Each module will be delivered in a 60- to 90-minute session. Module topics include (1) the leader's role; (2) starting a support group; (3) structuring a support group meeting; (4) scleroderma 101; (5) successful support group culture; (6 \&7) managing support group dynamics I and II; (8) grief and crisis in scleroderma; (9) marketing and recruitment; (10) the continuity of the group; (11) supporting yourself as a leader; (12) virtual support group meetings, (13) support group leader resources. Participants will receive a workbook, be shown filmed vignettes, and will have access to an online resource center.
Personal Health Questionnaire (PHQ-8)	0.38 score on a scale Interval -0.5 to 1.27

SECONDARY outcome

Timeframe: baseline and 13 weeks

The Patient Reported Outcomes Measurement Information System (PROMIS-29) measure contains 29 items, which include four items each for domains reflecting physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and ability to perform social roles, plus a single item on 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). High scores represent more of the domain being measured. Thus, on symptom-oriented domains, higher scores represent worse symptomatology. On the function-oriented domains, higher scores represent better functioning.The difference of pre- and post-trial means was calculated.

Outcome measures

Outcome measures
Measure	SPIN-SSLED Program n=10 Participants SPIN-SSLED Program: The program includes 13 modules that will be delivered live via webinar over the course of the 3-month program. Each module will be delivered in a 60- to 90-minute session. Module topics include (1) the leader's role; (2) starting a support group; (3) structuring a support group meeting; (4) scleroderma 101; (5) successful support group culture; (6 \&7) managing support group dynamics I and II; (8) grief and crisis in scleroderma; (9) marketing and recruitment; (10) the continuity of the group; (11) supporting yourself as a leader; (12) virtual support group meetings, (13) support group leader resources. Participants will receive a workbook, be shown filmed vignettes, and will have access to an online resource center.
Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0	0.45 score on a scale Interval -0.42 to 1.36

SECONDARY outcome

Timeframe: baseline and 13 weeks

The Oldenburg Burnout Inventory (OLBI) is a 16-item measure of burnout that assesses levels of exhaustion and disengagement in work populations. Items were adapted and reviewed by project investigators for use within the support group leader population. Items are scored on a 4-point scale from 1 (strongly disagree) to 4 (strongly agree). The total values range from 16 to 64, with higher score representing higher level of exhaustion and disengagement. The difference between pre- and post-trial means was calculated.

Outcome measures

Outcome measures
Measure	SPIN-SSLED Program n=10 Participants SPIN-SSLED Program: The program includes 13 modules that will be delivered live via webinar over the course of the 3-month program. Each module will be delivered in a 60- to 90-minute session. Module topics include (1) the leader's role; (2) starting a support group; (3) structuring a support group meeting; (4) scleroderma 101; (5) successful support group culture; (6 \&7) managing support group dynamics I and II; (8) grief and crisis in scleroderma; (9) marketing and recruitment; (10) the continuity of the group; (11) supporting yourself as a leader; (12) virtual support group meetings, (13) support group leader resources. Participants will receive a workbook, be shown filmed vignettes, and will have access to an online resource center.
Oldenburg Burnout Inventory (OLBI)	0.44 score on a scale Interval -0.44 to 1.33

Adverse Events

SPIN-SSLED 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

Dr. Brett Thombs

Lady Davis Institute

Phone: 514-340-8222

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place