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

被引：5

作者：

Kwakkenbos, Linda ^{[1
]}

Ostbo, Nora ^{[2
]}

Carrier, Marie-Eve ^{[2
]}

Nielson, Warren R. ^{[3
]}

Fedoruk, Claire ^{[2
]}

Levis, Brooke ^{[4
]}

Henry, Richard S. ^{[2
,5
]}

Pope, Janet ^{[6
]}

Frech, Tracy ^{[7
]}

Gholizadeh, Shadi ^{[8
]}

Johnson, Sindhu R. ^{[9
,10
,11
]}

Piotrowski, Pamela

Jewett, Lisa R. ^{[12
]}

Gordon, Jessica ^{[13
]}

Chung, Lorinda ^{[14
,15
]}

Bilsker, Dan ^{[16
,17
]}

Tao, Lydia ^{[2
]}

Turner, Kimberly A. ^{[2
]}

Cumin, Julie ^{[2
]}

Welling, Joep ^{[18
]}

Fortune, Catherine ^{[19
]}

Leite, Catarina ^{[20
]}

Gottesman, Karen ^{[21
]}

Sauve, Maureen ^{[22
,23
]}

Reyna, Tatiana Sofia Rodriguez ^{[24
]}

Hudson, Marie ^{[2
,25
]}

Larche, Maggie ^{[26
,27
]}

van Breda, Ward ^{[28
]}

Suarez-Almazor, Maria E. ^{[29
]}

Bartlett, Susan J. ^{[25
,30
]}

Malcarne, Vanessa L. ^{[31
,32
]}

Mayes, Maureen D. ^{[33
]}

Boutron, Isabelle ^{[34
,35
]}

Mouthon, Luc ^{[36
,37
]}

Benedetti, Andrea ^{[25
,38
,39
]}

Thombs, Brett D. ^{[2
,5
,25
,38
,40
,41
,42
]}

机构：

[1] Radboud Univ Nijmegen, Dept Clin Psychol, Montessorilaan 3, NL-6525 HR Nijmegen, Netherlands

[2] Jewish Gen Hosp, Lady Davis Inst, Montreal, PQ, Canada

[3] St Josephs Hlth Care, London, ON, Canada

[4] Keele Univ, Ctr Prognosis Res, Sch Med, Keele, Staffs, England

[5] McGill Univ, Dept Psychiat, Montreal, PQ, Canada

[6] Univ Western Ontario, Dept Med, London, ON, Canada

[7] Univ Utah, Dept Internal Med, Salt Lake City, UT 84112 USA

[8] Calif Sch Profess Psychol Alliant, Los Angeles, CA USA

[9] Mt Sinai Hosp, Toronto Scleroderma Program, Toronto, ON, Canada

[10] Toronto Western Hosp, Toronto, ON, Canada

[11] Univ Toronto, Inst Hlth Policy Management & Evaluat, Toronto, ON, Canada

[12] Jewish Gen Hosp, Inst Community & Family Psychiat, Dept Psychol, Montreal, PQ, Canada

[13] Hosp Special Surg, Dept Med, 535 E 70th St, New York, NY 10021 USA

[14] Stanford Univ, Dept Med, Palo Alto, CA USA

[15] Palo Alto VA Hlth Care Syst, Dept Med, Palo Alto, CA USA

[16] Simon Fraser Univ, Fac Hlth Sci, Burnaby, BC, Canada

[17] Univ British Columbia, Dept Psychiat, Vancouver, BC, Canada

[18] NVLE Dutch Patient Org Syst Autoimmune Dis, Utrecht, Netherlands

[19] Ottawa Scleroderma Support Grp, Ottawa, ON, Canada

[20] Univ Minho, Braga, Portugal

[21] Scleroderma Fdn, Los Angeles, CA USA

[22] Scleroderma Canada, Hamilton, ON, Canada

[23] Scleroderma Soc Ontario, Hamilton, ON, Canada

[24] Inst Nacl Ciencias Med & Nutr Salvador Zubiran, Mexico City, DF, Mexico

[25] McGill Univ, Dept Med, Montreal, PQ, Canada

[26] McMaster Univ, Dept Med, Hamilton, ON, Canada

[27] St Josephs Healthcare, Hamilton, ON, Canada

[28] Vrije Univ, Fac Behav & Movement Sci, Amsterdam, Netherlands

[29] Univ Texas MD Anderson Canc Ctr, Dept Gen Internal Med, Houston, TX 77030 USA

[30] McGill Univ Hlth Ctr, Ctr Outcomes Res & Evaluat, Res Inst, Montreal, PQ, Canada

[31] San Diego State Univ, Dept Psychol, San Diego, CA 92182 USA

[32] Univ Calif San Diego, San Diego State Univ, Joint Doctoral Program Clin Psychol, San Diego, CA 92103 USA

[33] Univ Texas McGovern Sch Med, Dept Internal Med, Houston, TX USA

[34] Univ Paris, Ctr Res Epidemiol & Stat CRESS, INRA, INSERM, Paris, France

[35] Hop Hotel Dieu, Assistance Publ Hop Paris AP HP, Ctr Epidemiol Clin, Paris, France

[36] Hop Cochin, Assistance Publ Hop Paris AP HP, Serv Med Interne, Ctr Reference Malad Autoimmunes Syst Rares Ile Fr, Paris, France

[37] Univ Paris, Hop Cochin, APHP CUP, F-75014 Paris, France

[38] McGill Univ, Dept Epidemiol Biostat & Occupat Hlth, Montreal, PQ, Canada

[39] McGill Univ Hlth Ctr, Resp Epidemiol & Clin Res Unit, Montreal, PQ, Canada

[40] McGill Univ, Dept Psychol, Montreal, PQ, Canada

[41] McGill Univ, Dept Educ & Counselling Psychol, Montreal, PQ, Canada

[42] McGill Univ, Biomed Eth Unit, Montreal, PQ, Canada

来源：

PILOT AND FEASIBILITY STUDIES | 2022年 / 8卷 / 01期

基金：

加拿大健康研究院;

关键词：

Feasibility trial; Scleroderma; Systemic sclerosis; Self-management; Internet intervention; Cohort multiple RCT; CHRONIC DISEASE SCALE; SYSTEMIC-SCLEROSIS; EDUCATION; HEALTH; OUTCOMES; ARTHRITIS; EFFICACY; VALIDITY; PROTOCOL; EVALUATE;

D O I：

10.1186/s40814-022-00994-5

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Background: The 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. Methods: This 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. Results: Of 40 SPIN Cohort participants randomized, 26 were allocated to SPIN-SELF and 14 to usual care. Auto-mated 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). Conclusions: The 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.

引用

页数：15

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