A randomized controlled trial evaluating the effectiveness of a self-management program for adolescents with a chronic condition: a study protocol.
Adolescent
Chronic condition self-management
Chronic illness
Concordance
Flinders Program
Patient compliance
Randomized controlled trial
Therapy adherence
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
05 Oct 2022
05 Oct 2022
Historique:
received:
07
04
2022
accepted:
13
09
2022
entrez:
5
10
2022
pubmed:
6
10
2022
medline:
12
10
2022
Statut:
epublish
Résumé
Self-management support is increasingly viewed as an integral part of chronic condition management in adolescence. It is well recognized that markers of chronic illness control deteriorate during adolescence. Due to the increasing prevalence of long-term chronic health conditions in childhood and improved survival rates of previously life-limiting conditions in children and adolescents, significant numbers of adolescents are having to manage their chronic condition effectively as they transition to adult health care. Therapy adherence has been identified as a major challenge for young people living with a chronic condition such as cystic fibrosis, diabetes, or asthma requiring long-term pharmacological therapy and/or lifestyle modifications. Most systematic reviews on self-management interventions address adult populations. Very few intervention studies are directed at adolescents with a chronic condition who are transitioning to adult health services. This protocol describes a prospective randomized controlled trial of a standardized self-management intervention program delivered to adolescents aged 15-18 years prior to their transfer to adult care. This study has been designed to provide evidence regarding self-management programs for adolescents and is the first study to use the Flinders Program with this important, under-researched age group. A randomized controlled trial is used to investigate the effectiveness of a modified adolescent-friendly version of an adult self-management program. This program is directed at improving self-management in an adolescent cohort 15-18 years of age with a chronic condition being treated in a specialist pediatric hospital. Participants will be randomized to either usual care or the modified Flinders Program plus usual care. Data collection will include measures of specific illness control, unscheduled hospital admissions, and questionnaires to record self-management competencies, quality of life, self-efficacy, and outcome measures specific to the chronic condition at baseline, 3 months, 6 months, and 12 months after delivery. This study will provide a better understanding of the elements required for effective self-management programs in adolescents with a chronic condition and address some important knowledge gaps in current literature. The study will be carried out in collaboration with the Discipline of Behavioural Health at Flinders University, Adelaide, Australia, in order to inform the development of an adolescent version of the successful and validated Flinders Program™. Australian and New Zealand Clinical Trials Registry (ACTRN12621000390886). Registered on April 8, 2021.
Sections du résumé
BACKGROUND
BACKGROUND
Self-management support is increasingly viewed as an integral part of chronic condition management in adolescence. It is well recognized that markers of chronic illness control deteriorate during adolescence. Due to the increasing prevalence of long-term chronic health conditions in childhood and improved survival rates of previously life-limiting conditions in children and adolescents, significant numbers of adolescents are having to manage their chronic condition effectively as they transition to adult health care. Therapy adherence has been identified as a major challenge for young people living with a chronic condition such as cystic fibrosis, diabetes, or asthma requiring long-term pharmacological therapy and/or lifestyle modifications. Most systematic reviews on self-management interventions address adult populations. Very few intervention studies are directed at adolescents with a chronic condition who are transitioning to adult health services. This protocol describes a prospective randomized controlled trial of a standardized self-management intervention program delivered to adolescents aged 15-18 years prior to their transfer to adult care. This study has been designed to provide evidence regarding self-management programs for adolescents and is the first study to use the Flinders Program with this important, under-researched age group.
METHODS
METHODS
A randomized controlled trial is used to investigate the effectiveness of a modified adolescent-friendly version of an adult self-management program. This program is directed at improving self-management in an adolescent cohort 15-18 years of age with a chronic condition being treated in a specialist pediatric hospital. Participants will be randomized to either usual care or the modified Flinders Program plus usual care. Data collection will include measures of specific illness control, unscheduled hospital admissions, and questionnaires to record self-management competencies, quality of life, self-efficacy, and outcome measures specific to the chronic condition at baseline, 3 months, 6 months, and 12 months after delivery.
DISCUSSION
CONCLUSIONS
This study will provide a better understanding of the elements required for effective self-management programs in adolescents with a chronic condition and address some important knowledge gaps in current literature. The study will be carried out in collaboration with the Discipline of Behavioural Health at Flinders University, Adelaide, Australia, in order to inform the development of an adolescent version of the successful and validated Flinders Program™.
TRIAL REGISTRATION
BACKGROUND
Australian and New Zealand Clinical Trials Registry (ACTRN12621000390886). Registered on April 8, 2021.
Identifiants
pubmed: 36199075
doi: 10.1186/s13063-022-06740-9
pii: 10.1186/s13063-022-06740-9
pmc: PMC9532816
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
850Informations de copyright
© 2022. The Author(s).
Références
Med Care. 2001 Aug;39(8):800-12
pubmed: 11468499
Patient Educ Couns. 2018 Apr;101(4):687-695
pubmed: 29129307
Med J Aust. 2007 Jan 15;186(2):84-7
pubmed: 17223770
Pediatrics. 2018 Mar;141(Suppl 3):S233-S241
pubmed: 29496974
Patient Educ Couns. 2019 Apr;102(4):607-622
pubmed: 30471988
Arch Dis Child. 2004 Oct;89(10):938-42
pubmed: 15383438
Health Qual Life Outcomes. 2017 Oct 27;15(1):215
pubmed: 29078774
Respir Care. 2012 Dec;57(12):2082-9
pubmed: 22710616
Pediatrics. 2015 May;135(5):789-92
pubmed: 25896841
Inflamm Bowel Dis. 2013 Jun;19(7):1534-45
pubmed: 23635715
Trials. 2015 Aug 17;16:352
pubmed: 26279154
PLoS One. 2015 Jul 10;10(7):e0130990
pubmed: 26162086
Pediatrics. 2017 May;139(5):
pubmed: 28557765
J Biomed Inform. 2009 Apr;42(2):377-81
pubmed: 18929686
Patient Educ Couns. 2015 Jun;98(6):704-15
pubmed: 25819373
Patient Educ Couns. 2010 Aug;80(2):205-11
pubmed: 19931372
Trends Cogn Sci. 2015 Oct;19(10):558-566
pubmed: 26419496
Med J Aust. 2005 Oct 17;183(8):405-9
pubmed: 16225444
World J Psychiatry. 2014 Jun 22;4(2):30-6
pubmed: 25019054
Am Fam Physician. 2005 Oct 15;72(8):1503-10
pubmed: 16273817
Trials. 2017 Jan 21;18(1):33
pubmed: 28109321
Holist Nurs Pract. 2016 Jan-Feb;30(1):39-46
pubmed: 26633725
Patient Educ Couns. 2002 Oct -Nov;48(2):177-87
pubmed: 12401421
Arthritis Rheum. 2008 Jan 15;59(1):65-72
pubmed: 18163408
Chronic Illn. 2020 Dec;16(4):239-252
pubmed: 30244592
Nephrol News Issues. 2015 Apr;29(4):22-3, 27-8, 30-2
pubmed: 26263750
Stat Med. 2015 Jan 30;34(2):181-96
pubmed: 25346484
Lancet. 2007 Apr 28;369(9571):1481-1489
pubmed: 17467519
Blood Purif. 2015;39(1-3):99-104
pubmed: 25662749
Cancer. 2002 Apr 1;94(7):2090-106
pubmed: 11932914
PLoS One. 2018 Apr 26;13(4):e0196562
pubmed: 29698459
Prev Chronic Dis. 2015 Jul 02;12:E103
pubmed: 26133646
Paediatr Child Health. 2008 Jan;13(1):19-24
pubmed: 19119348
Contemp Nurse. 2012 Feb;40(2):169-78
pubmed: 22554211
J Paediatr Child Health. 2008 Sep;44(9):478-82
pubmed: 18928466
J Adolesc Health. 2011 Nov;49(5):455-66
pubmed: 22018559
BMJ. 2005 Mar 26;330(7493):721-3
pubmed: 15790645
J Adv Nurs. 2021 Sep;77(9):3585-3599
pubmed: 33630315
Aust Fam Physician. 2007 Aug;36(8):622-7
pubmed: 17676185
Patient Educ Couns. 2015 Nov;98(11):1367-75
pubmed: 26146240
J Adolesc Health. 2014 Feb;54(2):121-38
pubmed: 24182940
Clin Respir J. 2011 Apr;5(2):64-75
pubmed: 21410898
Milbank Q. 2007;85(1):37-67
pubmed: 17319806
Lancet. 2007 Mar 31;369(9567):1130-9
pubmed: 17398312
Implement Sci. 2013 Jun 19;8:69
pubmed: 23782470
J Clin Epidemiol. 2010 Aug;63(8):e1-37
pubmed: 20346624
Child Care Health Dev. 2013 May;39(3):305-24
pubmed: 22676438
Contraception. 2013 Dec;88(6):676-7
pubmed: 24230918
Aust Health Rev. 2018 Sep;42(5):542-549
pubmed: 28835321
Psychol Med. 2002 Aug;32(6):959-76
pubmed: 12214795