Individual goal-based plan based on nursing theory for adults with type 2 diabetes and self-care deficits: a study protocol of a randomised controlled trial.
DIABETES & ENDOCRINOLOGY
PREVENTIVE MEDICINE
PRIMARY CARE
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
29 03 2022
29 03 2022
Historique:
entrez:
30
3
2022
pubmed:
31
3
2022
medline:
22
4
2022
Statut:
epublish
Résumé
The prevalence and costs of type 2 diabetes are increasing worldwide. A cornerstone in the treatment and care of diabetes is supporting each patient in self-management. In Sweden, most patients with type 2 diabetes are cared for in the primary care setting, which is heavily burdened. Because of implementation difficulties regarding evidenced-based diabetes self-management education and support in this setting, there is a need for an instrument that is easy to use and implement. We developed an individual care plan based on the self-care deficit nursing theory of Dorothea Orem as an instrument to facilitate more individualised self-care support for patients with type 2 diabetes. In this study, we aim to determine whether a written, theory-based, individual goal-based plan for patients with type 2 diabetes and self-management deficits can affect their glycaemic control and health-related quality of life, as well as their experiences of living with diabetes and of support from diabetes care. The study design is a randomised controlled trial using a quantitative approach. A total of 110 patients will be included. Additionally, a qualitative interview study will be conducted 12 months after the intervention. The primary outcome will be glycosylated haemoglobin levels. Secondary outcomes will be health-related quality of life measured using the RAND-36, and the patient's experience of living with diabetes and of the support from diabetes care measured using the Diabetes Questionnaire. Quantitative data will be analysed using the paired t-test, unpaired t-test, and Mann-Whitney U test with IBM SPSS V.26.0 software. Qualitative content analysis will be used for qualitative data. This study has been approved by the Ethical Review Authority in Uppsala, Sweden (Etikprövningsmyndigheten, Uppsala, Sverige) (Dnr: 2020-03421). The results will be disseminated in peer-reviewed publications. ISRCTN10030245.
Identifiants
pubmed: 35351707
pii: bmjopen-2021-053955
doi: 10.1136/bmjopen-2021-053955
pmc: PMC8966520
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e053955Informations de copyright
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
Références
BMJ Open. 2019 Jan 4;9(1):e025033
pubmed: 30612113
Diabetes Care. 2015 Feb;38(2):197-205
pubmed: 25125508
J Clin Nurs. 2020 May;29(9-10):1457-1476
pubmed: 31944439
Diabetes Care. 2020 Jul;43(7):1636-1649
pubmed: 32513817
Diabetes Res Clin Pract. 2018 Apr;138:271-281
pubmed: 29496507
J Patient Rep Outcomes. 2017;2(1):4
pubmed: 29757320
Diabetes Educ. 2020 Apr;46(2):139-160
pubmed: 31928334
Nurse Educ Today. 2004 Feb;24(2):105-12
pubmed: 14769454
J Am Board Fam Med. 2019 May-Jun;32(3):341-352
pubmed: 31068398
Prim Care Diabetes. 2015 Oct;9(5):338-45
pubmed: 25733343
Patient Educ Couns. 2018 Jan;101(1):139-146
pubmed: 28736071
Diabetes Res Clin Pract. 2011 Jan;91(1):54-60
pubmed: 21074887
J Hum Reprod Sci. 2011 Jan;4(1):8-11
pubmed: 21772732
Pharmacoecon Open. 2018 Dec;2(4):393-402
pubmed: 29623637
Ann Med. 2001 Jul;33(5):350-7
pubmed: 11491194
Lancet. 1998 Sep 12;352(9131):837-53
pubmed: 9742976
Afr Health Sci. 2016 Dec;16(4):1157-1162
pubmed: 28479909
Int J Nurs Sci. 2018 Dec 14;6(1):70-91
pubmed: 31406872
N Engl J Med. 2015 Oct 29;373(18):1720-32
pubmed: 26510021
Diabetes Res Clin Pract. 2019 Nov;157:107843
pubmed: 31518657
Qual Manag Health Care. 2011 Apr-Jun;20(2):89-97
pubmed: 21467895
J Manag Care Pharm. 2012 Sep;18(7):516-26
pubmed: 22971205
Eur J Pers Cent Healthc. 2017;5(2):213-219
pubmed: 28835847
Patient Educ Couns. 2016 Nov;99(11):1821-1829
pubmed: 27372525
Prim Health Care Res Dev. 2021 Sep 15;22:e46
pubmed: 34521493
BMC Public Health. 2011 Apr 28;11:267
pubmed: 21524316
Int J Nurs Pract. 2017 Oct;23(5):
pubmed: 28758701
Ethn Dis. 2017 Apr 20;27(2):155-160
pubmed: 28439186
Cochrane Database Syst Rev. 2009 Jan 21;(1):CD005268
pubmed: 19160249
BMJ. 2009 Jun 29;338:b2393
pubmed: 19564179
Diabetologia. 2020 Dec;63(12):2582-2594
pubmed: 32968866
Diabetes Care. 2016 Dec;39(12):2149-2157
pubmed: 27879359
PLoS One. 2019 Jun 5;14(6):e0217771
pubmed: 31166971
Creat Nurs. 2017 Feb 1;23(1):13-23
pubmed: 28196563
J Nurs Scholarsh. 2011 Sep;43(3):255-64
pubmed: 21884371
BMJ. 2000 Aug 12;321(7258):405-12
pubmed: 10938048
JAMA. 2017 Dec 19;318(23):2337-2343
pubmed: 29260229
Lakartidningen. 2013 Dec 4-17;110(49-50):2246-8
pubmed: 24494398
Am Heart J. 2013 Jul;166(1):179-86
pubmed: 23816038
Health Expect. 2021 Jun;24(3):1000-1008
pubmed: 33774899
Afr J Prim Health Care Fam Med. 2018 Nov 19;10(1):e1-e9
pubmed: 30456964