Evidence map›Paper›PMID 35219340›Full record

ArticlePilot and feasibility studies2022

Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program.

Linda Kwakkenbos, Nora Østbø, Marie-Eve Carrier, Warren R Nielson, Claire Fedoruk, Brooke Levis, Richard S Henry, Janet Pope, Tracy Frech, Shadi Gholizadeh and 27 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03914781 (Feasibility Trial of an Internet-based Self-management Program to Improve Disease-management Self-efficacy in Patients With Scleroderma), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03914781 nacompletednot on this map

Feasibility Trial of an Internet-based Self-management Program to Improve Disease-management Self-efficacy in Patients With Scleroderma: A Scleroderma Patient-centered Intervention Network (SPIN) Study

TypeinterventionalSponsorLady Davis InstituteRan2019 to 2019Enrolled40ConditionsScleroderma, Systemic SclerosisArmsSPIN-SELF Program
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

37 authors.

Linda KwakkenbosDepartment of Clinical Psychology, Radboud University, Montessorilaan 3, 6525, HR, Nijmegen, The Netherlands. kwakkenbosl@gmail.com.ORCID http://orcid.org/0000-0002-1573-4504
Nora ØstbøLady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada.
Marie-Eve CarrierLady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada.
Warren R NielsonSt. Joseph's Health Care, London, Ontario, Canada.
Claire FedorukLady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada.
Brooke LevisCentre for Prognosis Research, School of Medicine, Keele University, Staffordshire, UK.
Richard S HenryLady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada.
Janet PopeDepartment of Medicine, University of Western Ontario, London, Ontario, Canada.
Tracy FrechDepartment of Internal Medicine, University of Utah, Salt Lake City, UT, USA.
Shadi GholizadehCalifornia School of Professional Psychology/Alliant, Los Angeles, CA, USA.
Sindhu R JohnsonToronto Scleroderma Program, Mount Sinai Hospital & Toronto Western Hospital, Toronto, Ontario, Canada.
Pamela PiotrowskiPrivate practice - Nutrition, Hamilton, Ontario, Canada.
Lisa R JewettDepartment of Psychology, Institute of Community and Family Psychiatry, Jewish General Hospital, Montreal, Quebec, Canada.
Jessica GordonDepartment of Medicine, Hospital for Special Surgery, New York City, NY, USA.
Lorinda ChungDepartment of Medicine, Stanford University, Palo Alto, CA, USA.
Dan BilskerFaculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada.
Lydia TaoLady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada.
Kimberly A TurnerLady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada.
Julie CuminLady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada.
Joep WellingNVLE Dutch patient organization for Systemic Autoimmune Diseases, Utrecht, The Netherlands.
Catherine FortunéOttawa Scleroderma Support Group, Ottawa, Ontario, Canada.
Catarina LeiteUniversity of Minho, Braga, Portugal.
Karen GottesmanScleroderma Foundation, Los Angeles, CA, USA.
Maureen SauvéScleroderma Canada, Hamilton, Ontario, Canada.
Tatiana Sofia Rodriguez ReynaInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico, Mexico.
Marie HudsonLady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada.
Maggie LarcheDepartment of Medicine, McMaster University and St Joseph's Healthcare, Hamilton, Ontario, Canada.
Ward van BredaFaculty of Behavioural and Movement Sciences, Vrije University, Amsterdam, The Netherlands.
Maria E Suarez-AlmazorDepartment of General Internal Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Susan J BartlettDepartment of Medicine, McGill University, Montreal, Quebec, Canada.
Vanessa L MalcarneDepartment of Psychology, San Diego State University, San Diego, CA, USA.
Maureen D MayesDepartment of Internal Medicine, University of Texas McGovern School of Medicine, Houston, TX, USA.
Isabelle BoutronUniversité de Paris, Centre of Research Epidemiology and Statistics (CRESS), Inserm, INRA, Paris, France.
Luc MouthonService de Médecine Interne, Centre de Référence Maladies Autoimmunes Systémiques Rares d'Ile de France, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.
Andrea BenedettiDepartment of Medicine, McGill University, Montreal, Quebec, Canada.
Brett D ThombsLady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada.
SPIN Investigators

Funding

CIHR PJT-148504CIHR TR3-119192
6 · The paper itself

Abstract

backgroundThe Scleroderma Patient-centered Intervention Network (SPIN) developed an online self-management program (SPIN-SELF) designed to improve disease-management self-efficacy in people with systemic sclerosis (SSc, or scleroderma). The aim of this study was to evaluate feasibility aspects for conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF Program.

methodsThis feasibility trial was embedded in the SPIN Cohort and utilized the cohort multiple RCT design. In this design, at the time of cohort enrollment, cohort participants consent to be assessed for trial eligibility and randomized prior to being informed about the trial. Participants in the intervention arm are informed and provide consent, but not the control group. Forty English-speaking SPIN Cohort participants from Canada, the USA, or the UK with low disease-management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale [SEMCD] score ≤ 7) who were interested in using an online self-management program were randomized (3:2 ratio) to be offered the SPIN-SELF Program or usual care for 3 months. Program usage was examined via automated usage logs. User satisfaction was assessed with semi-structured interviews. Trial personnel time requirements and implementation challenges were logged.

resultsOf 40 SPIN Cohort participants randomized, 26 were allocated to SPIN-SELF and 14 to usual care. Automated eligibility and randomization procedures via the SPIN Cohort platform functioned properly, except that two participants with SEMCD scores > 7 (scores of 7.2 and 7.3, respectively) were included, which was caused by a system programming error that rounded SEMCD scores. Of 26 SPIN Cohort participants offered the SPIN-SELF Program, only 9 (35%) consented to use the program. Usage logs showed that use of the SPIN-SELF Program was low: 2 of 9 users (22%) logged into the program only once (median = 3), and 4 of 9 (44%) accessed none or only 1 of the 9 program's modules (median = 2).

conclusionsThe results of this study will lead to substantial changes for the planned full-scale RCT of the SPIN-SELF Program that we will incorporate into a planned additional feasibility trial with progression to a full-scale trial. These changes include transitioning to a conventional RCT design with pre-randomization consent and supplementing the online self-help with peer-facilitated videoconference-based groups to enhance engagement.

trial registrationclinicaltrials.gov , NCT03914781 . Registered 16 April 2019.

Indexed as

Cohort multiple RCTFeasibility trialInternet interventionSclerodermaSelf-managementSystemic sclerosis

Identifiers

PMID35219340
PMCPMC8881754

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.