Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Study protocol

A randomized controlled trial evaluating the effectiveness of a self-management program for adolescents with a chronic condition: a study protocol

Authors: Jaunna Gauci, Jacqueline Bloomfield, Sharon Lawn, Susan Towns, Annabelle Hobbs, Katharine Steinbeck

Published in: Trials | Issue 1/2022

Login to get access

Abstract

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

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

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

Australian and New Zealand Clinical Trials Registry (ACTRN12621000390886). Registered on April 8, 2021.
Appendix
Available only for authorised users
Literature
1.
Battersby M, et al. A pragmatic randomized controlled trial of the Flinders Program of chronic condition management in community health care services. Patient Educ Couns. 2015;98(11):1367–75.PubMedCrossRef
2.
3.
Towns SJ, Bell SC. Transition of adolescents with cystic fibrosis from paediatric to adult care. Clin Respir J. 2011;5(2):64–75.PubMedCrossRef
4.
AIHW. In: A.I.o.H.a. Welfare, editor. Young Australians: their health and wellbeing 2011. Canberra: AIHW; 2011.
5.
Kirk S. The effectiveness of self‐care support interventions for children and young people with long‐term conditions: a systematic review. Oxford: Blackwell Publishing Ltd; 2013. p. 305–24.
6.
Sawyer SM. Adolescents with a chronic condition: challenges living, challenges treating. Lancet (London, England). 2007;369(9571):1481–9.CrossRef
7.
Sawyer SM, Aroni, RA. Self-management in adolescents with chronic illness. What does it mean and how can it be achieved? Med J Aust. 2005;183(8):405–9.PubMedCrossRef
8.
Sawyer S, Duncan R, Drew S. Adolescents with chronic disease: the double whammy. Aust Fam Physician. 2007;36(6):622–3 625–7.PubMed
9.
Hanghoj S, Boisen KA. Self-reported barriers to medication adherence among chronically ill adolescents: a systematic review. J Adolesc Health. 2014;54(2):121–38.PubMedCrossRef
10.
Lozano P, Houtrow A. Supporting self-management in children and adolescents with complex chronic conditions. Pediatrics. 2018;141(Suppl 3):S233–41.PubMedCrossRef
11.
Fuhrmann D, Knoll LJ, Blakemore S-J. Adolescence as a sensitive period of brain development. Trends Cogn Sci. 2015;19(10):558–66.PubMedCrossRef
12.
Patton GC, Viner R. Pubertal transitions in health. The Lancet. 2007;369(9567):1130–9.CrossRef
13.
14.
Ahmed HA, et al. Managing ulcerative colitis in the adolescent: highlighting the developmental and self-management needs. Holist Nurs Pract. 2016;30(1):39–46.PubMedCrossRef
15.
Sattoe JNT, et al. Self-management interventions for young people with chronic conditions: A systematic overview. Patient Educ Couns. 2015;98(6):704–15.PubMedCrossRef
16.
Salema N-EM, Elliott RA, Glazebrook C. A systematic review of adherence-enhancing interventions in adolescents taking long-term medicines. J Adolesc Health. 2011;49(5):455–66.PubMedCrossRef
17.
Horne R, Weinman J, Barber N, Elliott R, Morgan M. Concordance, adherence and compliance in medicine - taking. Report for the National Co-ordinating Centre for NHS Service Delivery and Organisation R&D. London: National Coordinating Centre for the Service Delivery and Organisation (NCCSDO); 2005.
18.
19.
Coleman MT, Newton KS. Supporting self-management in patients with chronic illness. Am Fam Physician. 2005;72(8):1503–10.PubMed
20.
Ferris ME, et al. Self-management and transition among adolescents/young adults with chronic or end-stage kidney disease. Blood Purif. 2015;39(1–3):99–104.PubMedCrossRef
21.
Lindsay S, Kingsnorth S, Hamdani Y. Barriers and facilitators of chronic illness self-management among adolescents: a review and future directions. J Nurs Healthc Chronic Illn. 2011;3(3):186–208.CrossRef
22.
Paterson GA, Nayda RJ, Paterson JA. Chronic condition self-management: Working in partnership toward appropriate models for age and culturally diverse clients. Contemp Nurse. 2012;40(2):169–78.PubMedCrossRef
23.
Stinson JN, et al. Asking the experts: Exploring the self-management needs of adolescents with arthritis. Arthritis Care Res. 2008;59(1):65–72.CrossRef
24.
Lawn S, Schoo A. Supporting self-management of chronic health conditions: common approaches. Patient Educ Couns. 2010;80(2):205–11.PubMedCrossRef
25.
Henry HKM, Schor EL. Supporting self-management of chronic health problems. Pediatrics. 2015;135(5):789–92.PubMedCrossRef
26.
Greenley RN, et al. Practical strategies for enhancing adherence to treatment regimen in inflammatory bowel disease. Inflamm Bowel Dis. 2013;19(7):1534–45.PubMedCrossRef
27.
Slesnick N, et al. The chronic disease self-management program–A pilot study in patients undergoing hemodialysis. Nephrol News Issues. 2015;29(4):22–8.PubMed
28.
Pearson ML, Mattke S, Shaw R, Ridgely MS, Wiseman SH. Patient self-management support programs: an evaluation. Final Contract Report (Prepared by RAND Health under Contract No. 282–00–0005). Agency for Healthcare Research and Quality: Rockville; 2007.
29.
Saxby N, Beggs S, Kariyawasam N, Battersby M, Lawn S. Do guidelines provide evidencebased guidance to health professionals on promoting developmentally appropriate chronic condition selfmanagement in children? A systematic review. Chronic Illn. 2020;16(4):239–52. https://​doi.​org/​10.​1177/​1742395318799844​.
30.
31.
32.
Phillips GA, et al. Self-management and health care use in an adolescent and young adult medicaid population with differing chronic illnesses. Prev Chronic Dis. 2015;12(7):E103–E103.PubMedPubMedCentral
33.
Barlow J, et al. Self-management approaches for people with chronic conditions: a review. Patient Educ Couns. 2002;48(2):177–87.PubMedCrossRef
34.
Mammen JR, et al. Changes in asthma self-management knowledge in inner city adolescents following developmentally sensitive self-management training. Patient Educ Couns. 2018;101(4):687–95.PubMedCrossRef
35.
Jordan JE, Osborne RH. Chronic disease self-management education programs: challenges ahead. Med J Aust. 2007;186(2):84–7.PubMedCrossRef
36.
Gauci J, et al. Effectiveness of self-management programmes for adolescents with a chronic illness: A systematic review. J Adv Nurs. 2021;77(9):3585–99.PubMedCrossRef
37.
Hemming K, Lilford R, Girling AJ. Stepped-wedge cluster randomised controlled trials: a generic framework including parallel and multiple-level designs. Stat Med. 2015;34(2):181–96.PubMedCrossRef
38.
39.
Keriel-Gascou M, Buchet-Poyau K, Duclos A, Rabilloud M, Figon S, Dubois J-P, et al. Evaluation of an interactive program for preventing adverse drug events in primary care: study protocol of the InPAct cluster randomised stepped wedge trial. Implementation Science: IS, 2013;8(1):69–69. https://​doi.​org/​10.​1186/​1748-5908-8-69.
40.
Grayling MJ, Wason JMS, Mander AP. Stepped wedge cluster randomized controlled trial designs: a review of reporting quality and design features. Trials. 2017;18(1):33–33.PubMedPubMedCentralCrossRef
41.
Schulz KF, Grimes DA. Get in the spirit with SPIRIT 2013: protocol content guideline for clinical trials. Contraception (Stoneham). 2013;88(6):676–7.CrossRef
42.
Annual Review. Sydney Children's Hospitals Network; 2019.
43.
New South Wales. Ministry of Health & NSW Health, (contributor). Consent to medical and healthcare treatment manual. St Leonards: NSW Ministry of Health; 2020.
44.
Battersby M, et al. SA HealthPlus: a controlled trial of a statewide application of a generic model of chronic illness care. Milbank Q. 2007;85(1):37–67.PubMedPubMedCentralCrossRef
45.
Ajzen I. The theory of planned behavior. Organ Behav Hum Decis Process. 1991;50(2):179–211.CrossRef
46.
Battersby M, et al. A randomised trial of the Flinders Program to improve patient self-management competencies in a range of chronic conditions: study rationale and protocol. Australasian Med J. 2010;3:198–204.
47.
Chan J, McBurney H, Bell L. A pilot study to assess the efficacy of the Flinders Program of Chronic Condition Self-management on the health and wellbeing of haemodialysis patients. Renal Society Australasia J. 2014;10(2):66–74.
48.
Saxby N, et al. What are the components of effective chronic condition self-management education interventions for children with asthma, cystic fibrosis, and diabetes? A systematic review. Patient Educ Couns. 2019;102(4):607–22.PubMedCrossRef
49.
Steinbeck K, Lynne B, Susan T. Transition in chronic illness: who is going where? J Paediatr Child Health. 2008;44(9):478–82.PubMedCrossRef
50.
Boger E, et al. Self-management and self-management support outcomes: a systematic review and mixed research synthesis of stakeholder views. PLoS ONE. 2015;10(7):e0130990.PubMedPubMedCentralCrossRef
51.
Virella Pérez YI. Mobile Applications to Support Self-management and Transition in Young People with Chronic Illness. The University of Sydney; 2019.
52.
Lawn S, et al. Managing chronic conditions care across primary care and hospital systems: lessons from an Australian Hospital Avoidance Risk Program using the Flinders Chronic Condition Management Program. Aust Health Rev. 2017;42(5):542–9.CrossRef
53.
Battersby MW, et al. The Partners in Health scale: The development and psychometric properties of a generic assessment scale for chronic condition self-management. Australian J Primary Health. 2003;9(3):41–52.CrossRef
54.
Battersby MW, et al. The Partners in Health scale: the development and psychometric properties of a generic assessment scale for chronic condition self-management. Australian J Primary Health. 2003;9(3):41.CrossRef
55.
Varni JW, et al. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002;94(7):2090.PubMedCrossRef
56.
57.
58.
Varni JW, Seid M, Kurtin PS. PedsQL™ 4.0: Reliability and Validity of the Pediatric Quality of Life Inventory™ Version 4.0 Generic Core Scales in Healthy and Patient Populations. Med Care. 2001;39(8):800–12.PubMedCrossRef
59.
García-Ros R, Pérez-González F, Hinojosa E. Assessing time management skills as an important aspect of student learning: the construction and evaluation of a time management scale with Spanish high school students. Sch Psychol Int. 2004;25(2):167–83.CrossRef
60.
Britton BK, Tesser A. Effects of time-management practices on college grades. J Educ Psychol. 1991;83(3):405.CrossRef
61.
Alay S, Kocak S. Validity and reliability of time management questionnaire. Hacettepe Üniversitesi Eğitim Fakültesi Dergisi. 2002;22(2):9–13.
62.
63.
Kessler RC, et al. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002;32(6):959–76.PubMedCrossRef
64.
Sampasa-Kanyinga H, Zamorski MA, Colman I. The psychometric properties of the 10-item Kessler Psychological Distress Scale (K10) in Canadian military personnel. PLoS ONE. 2018;13(4):e0196562–e0196562.PubMedPubMedCentralCrossRef
65.
Suris JC, Michaud PA, Viner R. The adolescent with a chronic condition. Part I: developmental issues. Arch Dis Childhood. 2004;89(10):938.CrossRef
66.
Rhee H, McQuillan BE, Belyea MJ. Evaluation of a peer-led asthma self-management program and benefits of the program for adolescent peer leaders. (Report). Respiratory Care. 2012;57(12):2082.PubMedCrossRef
67.
68.
Harris PA, et al. Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81.PubMedCrossRef
Metadata
Title
A randomized controlled trial evaluating the effectiveness of a self-management program for adolescents with a chronic condition: a study protocol
Authors
Jaunna Gauci
Jacqueline Bloomfield
Sharon Lawn
Susan Towns
Annabelle Hobbs
Katharine Steinbeck
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06740-9

Other articles of this Issue 1/2022

Trials 1/2022 Go to the issue

Study protocol

Zoledronic Acid for prevention of bone and muscle loss after BAriatric Surgery (ZABAS)-a study protocol for a randomized controlled trial

Study protocol

Efficacy and safety of progressively reducing biologic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis in persistent remission: a study protocol for a non-inferiority randomized, controlled, single-blind trial

Study protocol

Efficacy of acupuncture on cognitive function in poststroke depression: study protocol for a randomized, placebo-controlled trial

Research

A single-dose, open-label, randomized, scintigraphic study to investigate the gastrointestinal behavior of 2 triple-combination cold products (acetaminophen, phenylephrine, and dextromethorphan) in healthy male volunteers

Study protocol

Effects of Bushen-Jiangya granules on blood pressure and pharmacogenomic evaluation in low-to-medium-risk hypertensive patients: study protocol for a randomized double-blind controlled trial

Research

Effect of new biological patch in repairing intrauterine adhesion and improving clinical pregnancy outcome in infertile women: study protocol for a randomized controlled trial