The Scleroderma Patient-Centered Intervention Network Self-Management Program: Protocol for a Randomized Feasibility Trial

被引：6

作者：

Carrier, Marie-Eve ^{[1
]}

Kwakkenbos, Linda ^{[2
]}

Nielson, Warren R. ^{[3
]}

Fedoruk, Claire ^{[1
]}

Nielsen, Karen ^{[4
]}

Milette, Katherine ^{[1
]}

Pope, Janet ^{[5
]}

Frech, Tracy ^{[6
]}

Gholizadeh, Shadi ^{[7
]}

Hummers, Laura ^{[8
]}

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

Piotrowski, Pamela

Jewett, Lisa

Gordon, Jessica ^{[12
]}

Chung, Lorinda ^{[13
,14
,15
,16
]}

Bilsker, Dan ^{[17
,18
]}

Turner, Kimberly A. ^{[1
]}

Cumin, Julie ^{[1
]}

Welling, Joep ^{[19
]}

Fortune, Catherine ^{[4
,20
]}

Leite, Catarina

Gottesman, Karen ^{[21
,22
]}

Sauve, Maureen ^{[4
,23
]}

Rodriguez-Reyna, Tatiana S. ^{[24
]}

Hudson, Marie ^{[25
]}

Larche, Maggie ^{[26
]}

van Breda, Ward ^{[27
]}

Suarez-Almazor, Maria E. ^{[28
]}

Bartlett, Susan J.

Malcarne, Vanessa L. ^{[29
]}

Mayes, Maureen D. ^{[30
]}

Boutron, Isabelle ^{[31
,32
]}

Mouthon, Luc ^{[31
,32
]}

Wigley, Fredrick ^{[8
]}

Thombs, Brett D. ^{[1
,33
,34
,35
]}

机构：

[1] Jewish Gen Hosp, Lady Davis Inst, 4333 Cote Ste Catherine Rd, Montreal, PQ H3T 1E4, Canada

[2] Radboud Univ Nijmegen, Clin Psychol, Behav Sci Inst, Nijmegen, Netherlands

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

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

[5] Univ Western Ontario, London, ON, Canada

[6] Univ Utah, Salt Lake City, UT USA

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

[8] Johns Hopkins Univ, Sch Med, Baltimore, MD USA

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

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

[11] Univ Toronto, Dept Surg, Div Neurosurg, Toronto, ON, Canada

[12] Hosp Special Surg, New York, NY USA

[13] Stanford Univ, Dept Pediat, Stanford, CA 94305 USA

[14] Stanford Univ, Dept Biomed Data Sci, Stanford, CA 94305 USA

[15] Stanford Univ, Dept Psychiat, Stanford, CA 94305 USA

[16] Stanford Univ, Dept Behav Sci, Stanford, CA 94305 USA

[17] Simon Fraser Univ, Burnaby, BC, Canada

[18] Univ British Columbia, Vancouver, BC, Canada

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

[20] Univ Minho, Braga, Portugal

[21] Scleroderma Fdn, Los Angeles, CA USA

[22] Scleroderma Canada, Hamilton, ON, Canada

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

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

[25] McMaster Univ, Hamilton, ON, Canada

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

[27] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA

[28] San Diego State Univ, San Diego, CA 92182 USA

[29] Univ Texas Houston, McGovern Sch Med, Houston, TX USA

[30] Univ Paris 05, Paris, France

[31] AP HP, Paris, France

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

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

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

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

来源：

JMIR RESEARCH PROTOCOLS | 2020年 / 9卷 / 04期

基金：

加拿大健康研究院;

关键词：

feasibility studies; scleroderma; systemic; self-management; trial protocols; EFFICACY-ENHANCING INTERVENTIONS; CHRONIC DISABILITY IMPLICATIONS; CHRONIC DISEASE SCALE; SYSTEMIC-SCLEROSIS; PILOT; EDUCATION; HEALTH; OUTCOMES; PRINT; SIZE;

D O I：

10.2196/16799

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

Background: Systemic sclerosis (SSc), or scleroderma, is a rare disease that often results in significant disruptions to activities of daily living and can negatively affect physical and psychological well-being. Because there is no known cure, SSc treatment focuses on reducing symptoms and disability and improving health-related quality of life (HRQoL). Self-management programs are known to increase self-efficacy for disease management in many chronic diseases. The Scleroderma Patient-centered Intervention Network (SPIN) developed a Web-based self-management program (SPIN self-management; SPIN-SELF) to increase self-efficacy for disease management and to improve HRQoL for patients with SSc. Objective: The proposed study aims to assess the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF program by evaluating the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-SELF program. Methods: The SPIN-SELF feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with low disease management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale score <= 7), who have indicated interest in using a Web-based self-management program, will be randomized with a 3:2 ratio into the SPIN-SELF program or usual care for 3 months. Feasibility outcomes include trial implementation processes, required resources and management, scientific aspects, and patient acceptability and usage of the SPIN-SELF program. Results: Enrollment of the 40 participants occurred between July 5, 2019, and July 27, 2019. By November 25, 2019, data collection of trial outcomes was completed. Data analysis is underway, and results are expected to be published in 2020. Conclusions: The SPIN-SELF program is a self-help tool that may improve disease-management self-efficacy and improve HRQoL in patients with SSc. The SPIN-SELF feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-SELF program.

引用

页数：15

共 39 条

[1] SELF-EFFICACY - TOWARD A UNIFYING THEORY OF BEHAVIORAL CHANGE [J].

BANDURA, A .

PSYCHOLOGICAL REVIEW, 1977, 84 (02) :191-215

[2] Self-management approaches for people with chronic conditions: a review [J].

Barlow, J ;

Wright, C ;

Sheasby, J ;

Turner, A ;

Hainsworth, J .

PATIENT EDUCATION AND COUNSELING, 2002, 48 (02) :177-187

[3] Frequency and impact of symptoms experienced by patients with systemic sclerosis: results from a Canadian National Survey [J].

Bassel, Marielle ;

Hudson, Marie ;

Taillefer, Suzanne S. ;

Schieir, Orit ;

Baron, Murray ;

Thombs, Brett D. .

RHEUMATOLOGY, 2011, 50 (04) :762-767

[4]

Canadian Organization for Rare Diseases, 2015, NOW IS TIM STRAT RAR

[5] CONSORT 2010 statement: extension to randomised pilot and feasibility trials [J].

Eldridge, Sandra M. ;

Chan, Claire L. ;

Campbell, Michael J. ;

Bond, Christine M. ;

Hopewell, Sally ;

Thabane, Lehana ;

Lancaster, Gillian A. .

BMJ-BRITISH MEDICAL JOURNAL, 2016, 355

[6]

European Commission, NAT PLANS STRAT RAR

[7]

Eurordis KA., 2009, VOICE 12000 PATIENTS

[8] Validity of Two New Patient-Reported Outcome Measures in Systemic Sclerosis: Patient-Reported Outcomes Measurement Information System 29-Item Health Profile and Functional Assessment of Chronic Illness Therapy-Dyspnea Short Form [J].

Hinchcliff, Monique ;

Beaumont, Jennifer L. ;

Thavarajah, Krishna ;

Varga, John ;

Chung, Anh ;

Podlusky, Sofia ;

Carns, Mary ;

Chang, Rowland W. ;

Cella, David .

ARTHRITIS CARE & RESEARCH, 2011, 63 (11) :1620-1628

[9]

Hoogeboom TJ, 2012, BMJ OPEN, V2, DOI [10.1136/bmjopen-2013-003563, 10.1136/bmjopen-2012-001161]

[10] Sample size of 12 per group rule of thumb for a pilot study [J].

Julious, SA .

PHARMACEUTICAL STATISTICS, 2005, 4 (04) :287-291

← 1 2 3 4 →