Original Research
Feasibility, Acceptability and Effects of a Foot Self-Care Educational Intervention on Minor Foot Problems in Adult Patients with Diabetes at Low Risk for Foot Ulceration: A Pilot Study

https://doi.org/10.1016/j.jcjd.2013.03.020Get rights and content

A b s t r a c t

Objectives

The objectives of the pilot study were to examine the feasibility and acceptability of the foot self-care educational intervention, and to explore its preliminary effects on reducing the occurrence of minor foot problems in adult patients with diabetes at low risk for foot ulceration.

Methods

A one-group-repeated-measures design was used. The intervention given over 3 weeks consisted of a 1 hour 1-on-1 provider-patient interaction to discuss foot self-care strategies, 1 hour hands-on practice of strategies and 2 10-minute telephone contact booster sessions. Of the 70 eligible consenting participants, 56 completed the study. The outcomes were assessed at pretest and at 3-month follow-up. Chi-square and Fisher's exact test were used to examine changes in outcomes over time.

Results

The findings provided initial evidence suggesting the foot self-care educational intervention is feasible and acceptable to adult patients with type 2 diabetes mellitus. It was effective in reducing the occurrence of minor foot skin and toenails problems (all p<0.05) at 3-month follow up.

Conclusions

The findings support the effects of the intervention. Future research should evaluate its efficacy using a randomized clinical trial design, and a large sample of patients with diabetes at low risk for foot ulcerations.

R é s u m é

Objectifs

Les objectifs de l'étude pilote étaient d'examiner la faisabilité et l'acceptabilité de l'intervention éducative en en matière d'autosoins des pieds, et d'explorer ses effets préliminaires sur la réduction de l'occurrence de problèmes mineurs aux pieds chez les patients adultes diabétiques ayant un faible risque d'ulcération du pied.

Méthodes

Un plan à mesures répétées constitué d'un seul groupe a été utilisé. L'intervention offerte durant 3 semaines a consisté en 1 heure d'interaction en face en face entre le prestataire et le patient pour discuter des stratégies en matière d'autosoins des pieds, 1 heure de pratique des stratégies et 2 séances téléphoniques de motivation de 10 minutes. Parmi les 70 participants consentants et admissibles, 56 ont complété l'étude. Les résultats ont été évalués avant les tests et au suivi de 3 mois. Le test du chi carré et le test exact de Fisher ont été utilisés pour examiner les changements relatifs aux résultats avec le temps.

Résultats

Les conclusions ont fourni des preuves initiales suggérant que l'intervention éducative en matière d'autosoins des pieds est réalisable et acceptable pour les patients adultes ayant le diabète sucré de type 2. Elle a été efficace à la réduction de l'occurrence de problèmes mineurs cutanés des pieds et unguéaux des orteils (tous p < 0,05) au suivi de 3 mois.

Conclusions

Les conclusions appuient les effets de l'intervention. D'autres recherches devraient évaluer son efficacité en utilisant un plan d'essai clinique aléatoire et un vaste échantillon de patients diabétiques ayant un faible risque d'ulcération du pied.

Introduction

Foot ulceration is a common, serious and expensive chronic complication for persons with diabetes (1). The prevalence of foot ulcerations ranges from 4% to 10% among patients with type 2 diabetes mellitus (2), with a lifetime risk of developing a foot ulcer as high as 25% (3). If not treated appropriately, foot ulcerations contribute up to 85% of lower extremity amputations (4). Foot ulcerations and subsequent lower extremity amputation are associated with high diabetes-related hospitalizations, negative emotional reactions, physical suffering, loss of productivity, reduced quality of life and a huge financial burden for patients and the healthcare system in developed and developing countries 3, 5.

Much effort and research have been directed toward patient education to prevent foot complications among patients with diabetes during the past decades. Although a recent systematic review suggests that there is insufficient robust evidence that limited patient education alone is effective in achieving clinically relevant reductions in ulcer and amputation incidence (6), results of previous studies indicated that patient education on foot self-care plays a significant role in preventing foot complications in patients with diabetes, reducing the risk of diabetes-related foot complications by an estimated 49% to 85%; results of experimental studies that evaluated educational interventions supported their effectiveness in improving patients' foot self-care knowledge and behaviour, and reducing the rate of foot ulceration and amputation, particularly in high-risk patients 1, 3, 6, 7, 8. It is uncertain, however, whether development of minor foot problems (i.e. calluses, skin dryness and cracking, infection and trauma) that contribute to ulceration could be significantly reduced in patients with diabetes at low risk for foot complications.

Minor foot problems are common in individuals with diabetes and can lead to foot ulcers and lower extremity amputation if delayed or inappropriate treatment is given (9). Eighty-six percent of the eventual amputations resulted from a pivotal triggering event that is preventable; the event frequently involves a minor foot trauma such as wearing improper shoes and improper cutting of toenails. The devastating consequences of foot ulceration could be avoided in most cases 10, 11. Therefore, it is necessary to design and pilot explore the effects of educational interventions in preventing minor foot problems that can lead to ulceration and subsequent amputation in patients with diabetes.

In most experimental studies, evaluating foot self-care educational interventions, focusing on high risk, or a mix of participants at high and low risk for ulceration were included 1, 3, 6, 7, 8, 11. Participants at different risk for ulceration may respond differently to the intervention that affects the magnitude of its effects on the immediate and ultimate outcomes 7, 12, 13. Limited research has focused on the effects of educational interventions in patients with diabetes at low risk for foot ulceration. The latter group of patients who are majority of newly diagnosed, general diabetes population (14) may receive little, if any, information about foot complications and how to prevent them. Prevention of foot ulceration is far more important than its treatment. The potential consequences of poor foot care in diabetes are grave. The importance of foot health and foot care must be communicated at an early stage of the disease (15). To be more effective in preventing and reducing minor foot problems, and consequently preventing the development of major foot problems such as foot ulcerations and lower extremity amputation, foot self-care educational interventions must start as early as possible; that is, patient education should be initiated in patients with diabetes at low risk of developing foot ulcers, so that primary prevention of foot ulceration can be successfully achieved 15, 16. We designed a new educational intervention to enhance foot self-care among patients with diabetes at low risk of ulceration. The specific objectives of this pilot study were to examine the feasibility and acceptability of the intervention (17), and to explore the preliminary effects on reducing minor foot problems in adult patients with type 2 diabetes at low risk for foot ulceration.

Section snippets

Research design and sample

A 1-group pretest and posttest design was used to address the study objectives. After obtaining approval by the Research Ethics Board at the University of Toronto, the recruitment began at a family health team clinic. Participants were eligible if they: 1) had a diagnosis of type 2 diabetes, 2) have not received formal diabetes education, 3) resided in the family health team clinic's catchment area and were not planning to be away for at least 3 months, 4) were able to attend the on-site

Initial interest rate

A total of 94 persons with diabetes inquired about the study, and were screened for eligibility. Of these, 79 persons met the study eligibility criteria representing 87.7% of screened persons.

Enrollment rate

Nine of the 79 eligible persons declined further enrollment in the study. Three persons did not provide a specific reason for refusal. The remaining 6 persons offered the following reasons: family issue such as taking care of husband who had stroke at home (n=1); time issue such as inability to take days

Feasibility of the intervention

Several indicators have been used to assess the feasibility of an intervention 25, 37, 38. The most frequently reported indicators included participants' enrollment, attendance at the intervention sessions, adherence to intervention and withdrawal. Attendance at the intervention sessions also was used to reflect intervention acceptability in a diabetes self-management support intervention (39). The present study used Cole and Dendukuri's (25) definition of feasibility, that is, the feasibility

Conclusions

The results of this pilot study provided preliminary evidence that the intervention is feasible, acceptable and effective in reducing the occurrence of minor foot problems in patients with type 2 diabetes at low-risk for foot ulceration in a 3-month short-term period. Future research should evaluate its efficacy using a randomized clinical trial design, a large sample of patients with diabetes at low risk for foot ulcerations, and long-term evaluation of the foot self-care educational

Acknowledgements

Financial support received from the Provincial Nurse Educators Interest Group Research Award, Registered Nurses Association of Ontario; and Faculty of Nursing, University of Toronto.

References (45)

  • J.A. Dorrestijn et al.

    Patient education for preventing diabetic foot ulceration

    The Cochrane Database of Systematic Reviews

    (2012 October 17)
  • J.A. Mayfield et al.

    Preventive foot care in people with diabetes

    Diabetes Care

    (1998)
  • J. Apelqvist et al.

    International Consensus and practical guidelines on the management and the prevention of the diabetic foot. International Working Group on the Diabetic Foot

    Diabetes Metab Res Rev

    (2000)
  • H. Hamalainen et al.

    Long-term effects of one year of intensified podiatric activities on foot-care knowledge and self-care habits in patients with diabetes

    Diabetes Educ

    (1998)
  • J.E. Halpin-Landry et al.

    Feet first. Diabetes care

    Am J Nurs

    (1999)
  • D.K. Litzelman et al.

    Reduction of lower extremity clinical abnormalities in patients with non-insulin-dependent diabetes mellitus

    Ann Intern Med

    (1993)
  • International Working Group on the Diabetic Foot. Practical guidelines on the management and prevention of the diabetic...
  • Registered Nurses Association of Ontario (RNAO)

    Reducing foot complications for people with diabetes

    (2004)
  • A. McInnes et al.

    Foot care education in patients with diabetes at low risk of complications: a consensus statement

    Diabetic Med

    (2011)
  • J. Apelqvist et al.

    What is the most effective way to reduce incidence of amputation in the diabetic foot?

    Diabetes Metab Res Rev

    (2000)
  • R. Whittemore et al.

    The systematic development of nursing interventions

    J Nurs Scholarship

    (2002)
  • M.A. Hertzog

    Considerations in determining sample size for pilot studies

    Res Nurs Health

    (2008)
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