Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04246528 |
| Other study ID # |
2021-2777 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 15, 2021 |
| Est. completion date |
May 2026 |
Study information
| Verified date |
October 2023 |
| Source |
Lady Davis Institute |
| Contact |
Brett D Thombs, PhD |
| Phone |
514-340-8222 |
| Email |
brett.thombs[@]mcgill.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The Scleroderma Patient-centered Intervention Network (SPIN) is an organization established
by researchers, health care providers, and people living with scleroderma (systemic
sclerosis; SSc) from Canada, the United States, Mexico, Australia, France, Spain, and the
United Kingdom. The objectives of SPIN are (1) to assemble a large cohort of SSc patients who
complete outcome assessments regularly in order to learn more about important problems faced
by people living with SSc and (2) to develop and test a series of internet-based
interventions to help patients manage problems related to SSc, including a self-management
program (SPIN-SELF Program).
The SPIN-SELF Program was designed by SPIN members based on key tenets of behaviour change
that have been successfully incorporated in programs for more common diseases and on patient
input. It utilizes social modelling through educational videos of SSc patients describing
their challenges and what they have done to cope with SSc, as well as videos teaching key
self-management techniques. After an introduction to self-management and instructions on how
to navigate the program, patients will have access to modules that are most relevant to their
symptoms and disease management challenges. The program's modules address (1) pain; (2) skin
care, finger ulcers, and Raynaud's; (3) sleep problems; (4) fatigue; (5) gastrointestinal
symptoms; (6) itch; (7) emotions and stress; (8) body image concerns due to disfigurement;
and (9) effective communication with healthcare providers.
The proposed study is a feasibility trial with progression to full-scale randomized
controlled trial (RCT), depending on whether stoppage criteria are met, of the SPIN
Self-Management Program. The SPIN-SELF Program was previously feasibility tested as an online
only, self-help intervention. However, uptake was low, thus the investigators have moved to a
group-based format. SPIN-SELF participants randomized to intervention will access and use
online self-management material, and this will be supported by videoconference group
sessions, led by trained peer facilitators.
In the SPIN-SELF feasibility trial with progression to full-scale trial, the investigators
will evaluate the disease management self-efficacy of participants who use SPIN-SELF compared
to usual care. Eligible SPIN Cohort participants and externally recruited participants, with
low disease-management self-efficacy, will be randomized to the SPIN-SELF Program or to usual
care only. In the feasibility portion, 40 eligible participants will be randomized. Unless
the trial team determines, based on stoppage criteria, that trial procedures need important
modifications thereby re-setting the full scale trial as a new trial, the outcome data of the
participants in the feasibility portion will be utilized in the analyses of the full-scale
trial. In the full-scale RCT, 524 participants will be randomized.
Description:
----------------------- OBJECTIVES
The primary objective of the SPIN-SELF feasibility trial with progression to full-scale RCT
is to evaluate the disease management self-efficacy of participants who use SPIN's online
self-management program (SPIN-SELF), compared to usual care. Secondary objectives are to
assess the effect of SPIN-SELF on patient activation (i.e. the extent to which patients
effectively engage with and manage their own health), social appearance anxiety, functional
health outcomes, as well as usage of the SPIN-SELF program and patient satisfaction with the
format and delivery.
----------------------- RECRUITMENT
The SPIN Cohort currently includes over 2000 SSc patients from 47 sites in Canada, the United
States, Mexico, Australia, and France, Spain, and the United Kingdom. SPIN Cohort
participants complete outcome measures via the Internet upon enrolment and subsequently every
three months. Eligible patients, based on questionnaire responses (Self-Efficacy for Managing
Chronic Disease (SEMCD) Scale ≤ 7), will be invited to participate in the SPIN-SELF
feasibility trial with progression to full-scale trial. Additionally, recruitment
announcements for the SPIN-SELF feasibility and full-scale trials will be posted on SPIN's
Facebook page and Twitter account and distributed for posting via SPIN's patient organization
partners in countries with large English and French-speaking populations. The non-SPIN Cohort
participants' eligibility will be assessed with the SEMCD Scale. In the feasibility portion,
only English-speaking participants will be included. In the full-scale trial, English and
French-speaking participants will be included. An anticipated 40 eligible participants will
be recruited into the feasibility portion, and an anticipated 524 eligible participants will
be recruited into the SPIN-SELF full-scale RCT.
----------------------- PROGRESSION FROM SPIN-SELF FEASIBILITY TRIAL TO FULL-SCALE TRIAL
The investigators will launch the SPIN-SELF trial as a feasibility trial with possible
progression to full-scale trial. Thus, in the feasibility portion of the proposed study, the
trial team will collect data to improve several aspects of the trial's processes. At the
completion of the feasibility portion, the trial team plans to proceed directly to the
full-scale trial, including results from the feasibility stage in the full-scale trial,
unless one or more of the stoppage criteria occur. In that case, the trial team will address
issues that are identified and begin the full-scale trial anew, separate from the feasibility
trial. The stoppage criteria are the following:
1. Recruitment and enrolment of trial participants: If participants who are eligible based
on their self-efficacy scores (SEMCD ≤ 7) are not recorded as eligible in the
eligibility report on the new SPIN Cohort platform (gen2) and not recruited, then the
programming errors in the new platform will need to be addressed and procedures will
need to be re-set before the full-scale trial can commence. If more than 6 non-eligible
participants (15% of 40 enrolled in feasibility trial) are erroneously identified as
eligible and assigned to the intervention or waitlist control, the trial team would
address programming errors, modify procedures and conduct the full-scale trial as a new
trial.
2. Fidelity of the delivery of the intervention (i.e., group sessions): If by the end of
the feasibility trial > 20% of the components of the 8 sessions were not delivered
according to the pre-specified program, the trial team will investigate to identify
barriers to the delivery of the intervention and will modify the intervention procedures
accordingly, before proceeding to the full-scale trial. The full-scale trial would need
to commence as a new trial.
3. Group format of the SPIN-SELF sessions: If participants across groups consistently
suggest similar changes to the format of the SPIN-SELF program, then the trial team
would modify the format of the intervention sessions according to this consensus
feedback. These modifications would be made before commencing the full-scale trial as a
new trial.
At the end of the SPIN-SELF feasibility trial, the investigators will use the collected
information and evaluation of the stoppage criteria to decide whether to: (1) Continue
to the full-scale RCT without modifications to the trial procedures, (2) Modify trial
procedures based on participant feedback before continuing to the full-scale trial, or
(3) Modify the trial procedures before re-setting them and conducting the full-scale RCT
as a new trial (in this case, outcome data collected during the feasibility phase will
not be included in the analyses of the full-scale trial).
----------------------- RANDOMISATION
Monthly, consented participants will be entered into pools based on language and
scheduling availability. De-identified codes for participants in each pool will be
provided to an external randomisation service. Starting with the largest pool, the
service will randomly select the largest possible even number of participants (12 to 20
participants) then randomly allocate half to intervention and half to control via single
block randomisation using R version 3.6.3. This will be repeated to form as many groups
of 6-10 participants and paired waitlist participants as possible each month until the
enrolment target is met.
----------------------- INTERVENTION
The SPIN-SELF Program is an 8-session group videoconference intervention that is
delivered over the course of 12 weeks. Each videoconference-based intervention group
will be led by a facilitator who has been trained in the SPIN- Scleroderma Support Group
Leader Education (SSLED) Program.
----------------------- STATISTICAL ANALYSES
Consistent with the feasibility trial design and small sample size, no hypothesis tests
are planned for the feasibility portion of the trial. Instead, the investigators will
present a description of the feasibility elements, including participants' eligibility
and recruitment and numbers and percentages of participants who respond to follow-up
measures. Use of the internet intervention will be described by presenting the frequency
of logins and usage of the specific SPIN-SELF modules. Analysis of outcome measures will
include the completeness of data and presence of floor or ceiling effects. Descriptive
statistics will be used to provide means and standard deviations for the measures.
Qualitative information on participants' experience using the SPIN-SELF intervention
will be used to interpret acceptability related to the group-sessions format, content of
the sessions and online program, webpage organization, and navigation. Information
related to required resources and management of the program during feasibility will
inform any necessary changes to intervention or trial procedures.
In the full-scale trial, for continuous outcomes, the investigators will use an
intent-to-treat analysis to estimate score differences between intervention and waitlist
participants with a linear mixed-effects model fit using the lmer function in lme4.
Score differences and Hedges' g SMD effect size will be presented with 95% confidence
intervals (CIs). To estimate odds ratios for the dichotomous MCID, intent-to-treat
analysis will be done with a binomial generalized linear mixed-effects models with a log
link function fit using the glmer function in lme4.
For all models, to account for clustering in the blocked PN-RCT design, the
investigators will fit a random intercept and slope for treatment effect by
randomisation block and an additional random slope for treatment by intervention group
cluster. In main analyses, in addition to a fixed effect for assignment to the
intervention arm, the investigators will include a fixed effect for baseline score. In
adjusted analyses, the investigators will also control for age (years), sex (male vs.
female), SSc disease subtype (diffuse vs. limited), disease duration (years since
diagnosis), and country (Canada, France, USA, other) as fixed effects.
In the event of missing outcome data, to minimize the possibility of bias, the
investigators will use multiple imputation by chained equations using the mice package
to generate 20 imputed datasets, using 15 cycles per imputed dataset. Variables in the
mice procedure will include randomisation block, intervention arm, number of
intervention sessions attended, measures of all primary and secondary outcomes at
baseline and post-intervention, age, sex, SSc disease subtype, years since diagnosis,
country, and race/ethnicity. Pooled standard errors and associated 95% CIs will be
estimated using Rubin's rules.
To estimate average intervention effects among compliers, which will be defined based on
the number of sessions completed, the investigators will use an instrumental variable
approach to inflate intent-to-treat effects from main models by the inverse probability
of compliance among intervention arm participants; 95% CIs will be constructed via a
cluster bootstrap approach, resampling at study randomisation block and participant
levels. For transparency, results for participants with complete data will also be
shown. Participant satisfaction scores for the intervention group will be reported
descriptively. All outcome analyses will be conducted in R (R version 3.6.3; R Studio
version 1.2.5042). All analyses will be 2-sided with alpha = 0.05. The investigators
will not adjust for multiple analyses since a single primary outcome was identified a
priori.
