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Patient education for the prevention of diabetic foot ulcers. Interim analysis of a randomised controlled trial due to morbidity and mortality of participants
Malmö högskola, Faculty of Health and Society (HS).ORCID iD: 0000-0003-4395-2522
Malmö högskola, Faculty of Health and Society (HS).ORCID iD: 0000-0001-9065-6377
2011 (English)In: European Diabetes Nursing, ISSN 1551-7853, E-ISSN 1551-7861, Vol. 8, no 3, p. 102-107bArticle in journal (Refereed)
Abstract [en]

This study was designed to explore whether participant-driven patient education in group sessions, compared to provision of standard information, will contribute to a statistically significant reduction in new ulceration during 24 months in patients with diabetes and high risk of ulceration. This is an interim analysis after six months. A randomised controlled study was designed in accordance with CONSORT criteria. Inclusion criteria were: age 35–79 years old, diabetes mellitus, sensory neuropathy, and healed foot ulcer below the ankle; 657 patients (both male and female) were consecutively screened. A total of 131 patients (35 women) were included in the study. Interim analysis of 98 patients after six months was done due to concerns about the patients’ ability to fulfil the study per protocol. After a six-month follow up, 42% had developed a new foot ulcer and there was no statistical difference between the two groups. The number of patients was too small to draw any statistical conclusion regarding the effect of the intervention. At six months, five patients had died, and 21 had declined further participation or were lost to follow up. The main reasons for ulcer development were plantar stress ulcer and external trauma. It was concluded that patients with diabetes and a healed foot ulcer develop foot ulcers in spite of participant-driven group education as this high risk patient group has external risk factors that are beyond this form of education. The educational method should be evaluated in patients with lower risk of ulceration. Eur Diabetes Nursing 2011; 8(3): 102–107

Place, publisher, year, edition, pages
John Wiley & Sons, 2011. Vol. 8, no 3, p. 102-107b
Keywords [en]
diabetes mellitus, diabetic foot ulcers, neuropathy, patient education, randomised controlled trial
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:mau:diva-15246DOI: 10.1002/edn.189Scopus ID: 2-s2.0-82455217325Local ID: 12880OAI: oai:DiVA.org:mau-15246DiVA, id: diva2:1418767
Available from: 2020-03-30 Created: 2020-03-30 Last updated: 2024-02-05Bibliographically approved
In thesis
1. Prevention of foot ulcers in patients with diabetes mellitus
Open this publication in new window or tab >>Prevention of foot ulcers in patients with diabetes mellitus
2011 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Amputation in patients with diabetes mellitus preceded by a foot ulcer is a serious complication. Patients with the highest risk of developing a foot ulcer are often found in home nursing settings. The overall aim was to focus on how registered nurses are working with prevention of foot ulcers in patients with diabetes mellitus in outpatient settings: - to identify factors related to short term outcome of foot ul-cers in patients treated in a multi-disciplinary system until healing was achieved. - to assess what was documented by registered nurses regarding diabetes care in a Swed-ish municipality’s home nursing service; to what extent nursing actions were planned for, performed and evaluated according to the goals of metabolic control, treatment and prevention of complications.- to explore registered nurses’ professional work with foot ulcer prevention in home nursing settings. - to explore whether participant driven group information has an impact on ulceration in a patient group with previ-ous diabetes foot ulcer. Study I used logistic regression analysis to identify factors related to outcome in a cohort of 2480 consecutive patients with diabetic foot ulcer at a multidisciplinary foot clinic. Results: Healed primarily: 65% (n=1617), 9% (n=250) after minor am-putation, 8% (n=193) after major amputation and 17% (n=420) died unhealed. Primary healing was related to co- morbidity, duration of diabetes, extent of periph-eral vascular disease and type of ulcer. In neuropathic ulcers, deep foot infection, site of ulcer and co-morbidity was related to amputation. In neuro-ischemic/ischemic ul-cers amputation was related to co morbidity, peripheral arterial disease and type of ulcer. Study II was a cross sectional assessment of all nursing records of patients with dia-betes (N=172) in a municipality’s home nursing setting and analyzed with manifest content analysis. Results: The overall standard of nursing records was insufficient. Evaluation of blood glucose was documented in 61% (n=105) of the records, weight was documented in 6% (n=10), blood pressure in 10% (n=17) and ongoing foot ul-cers were documented in 21% (n=36). Study III was a qualitative interview study of 15 registered nurses from four munici-palities, analyzed with manifest content analysis. Results: Registered nurses in home nursing settings worked mainly through health care assistants. The nurses used lead-ership and education as the main tools to enable the nursing process. They mainly relied on experience based competence. Study IV was a randomized controlled trial comparing participant driven education in group with standard information, in patients with diabetes and previous foot ul-cers. An interim analysis was made 6 months after intervention of 131 included pa-tients. Results: After 6 months follow up, 58% (n=57) of the 98 evaluated patients had not developed a new foot ulcer. There was no statistical difference between the two interventions. The most common reasons for ulceration were plantar stress ulcer and minor external trauma. Five patients had deceased and 10 had withdrawn con-sent to participate. Conclusion: Patients with diabetes and high risk of developing foot ulcer constitute a fragile group that needs special foot protective attention. This requires a well edu-cated staff in the home nursing organization. In the future patient education should target low risk patients.

Place, publisher, year, edition, pages
Malmö University, 2011
Series
Malmö University Health and Society Dissertations, ISSN 1653-5383
Keywords
amputation, complications, diabetes mellitus, diabetic foot ulcers, documentation, education, healing, home care, neuropathy, nursing, nursing process, peripheral vascular disease, pressure ulcer, prevention, RCT
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:mau:diva-7351 (URN)12383 (Local ID)978-91-7104-412-9 (ISBN)12383 (Archive number)12383 (OAI)
Note

Paper III and IV in dissertation as manuscript, paper III with title "Prevention of foot ulcers in patients with diabetes in home nursing settings – an interview study among registered nurses"

Available from: 2020-02-28 Created: 2020-02-28 Last updated: 2024-03-04Bibliographically approved

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Annersten Gershater, MagdalenaAlm-Roijer, Carin

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