Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration: a Pilot Study

NCT ID: NCT01731808

Last Updated: 2014-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-03-31

Brief Summary

The purpose of the study is to evaluate the feasibility and effectiveness of a physician directed nurse managed earlier outpatient counselling intervention for patients with diabetic foot ulceration.

For the purpose effectiveness is defined in two ways.1) as a reduction in hospital readmissions for complication for foot ulcers such as amputation or increased severity of the ulcer and 2) reduction in amputations, readmission rates. Selected covariates (self-efficacy,self-management, social support and depression) will be included to estimate predictors for readmission and amputation.

Detailed Description

Diabetes mellitus (DM) is associates with numerous complications. One of these is decreased peripheral circulation impaired sensation leading to the development of foot ulcers that lead to amputations of toes, feet and limbs. These complications not only have devastating effects on the individual in terms of loss of functionality but also impact the patient's ability to carry out and enjoy occupational, recreational and family functioning activities. Furthermore, foot ulcers and associated problems often lead to prolonged hospitalization and loss of productivity. All of these have personal as well as societal economical implications.

Currently, the standard of care includes admissions to the hospital lasting up to six weeks for medical observations and treatment of food ulcers.

The nursing responsibilities include daily or more frequent wound care as well as education counselling and skill building for diabetes self-management; therefore, an alternative to current practices must be considered. Such an alternative strategy has the potential benefit for the patient as well as the societal benefit of economic savings should such an outpatient nurse managed intervention be as or more effective as current practice. This type of service would allow the patients to remain in their home for care with probably a reduced risk for nosocomial infections.

This pilot randomized clinical trial (RCT) aims to evaluate the feasibility of an additional patient education program to current management of foot care in patients with DM. We plan to determine whether foot ulcer care in hospital under medical and nursing management can be improved by early discharge of the Intervention group (IG) to the well established outpatient wound care combined with an additional new outpatient nurse managed counselling program.

Expected results:

This study aims to test an alternative to current standard of care for patients with foot ulcers. A RCT is the preferred method to establish efficacy for this alternative nurse managed intervention; and if found to be effective, the current study will also allow an evaluation of the cost effectiveness of this intervention and the potential economic reduction in cost to the health care system.

Also, patients in the hospital are in danger of acquiring nosocomial infections, are subject to medical and nursing errors and are potentially accident prone; all of this together with a general preference for being able to live at home as compared to the hospital, together with the cost savings mentioned above could have a considerable impact on patient's quality of life, satisfaction with care, improvement in food ulcer and amputation outcomes.

Significance:

The potential implications are major in terms of quality of life, reduction in morbidity in disability days, and cost savings. It is anticipated that this intervention is at least as effective as hospital stay, and being surrounded by their own loved ones without the threats that a hospital setting presents. The findings will be important to consider whether clinical practice can be changed to benefit patients. If the study results show that the subjects in the IG have better skills in monitoring and treating their diabetic foot ulcerations and eventually avoid developing further complications the intervention can be applied to future patients.

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Standard care

All participants received three specially-developed brochures with information regarding the diabetic foot condition. The brochures contained explanations to a) the cause and warning signs of diabetic foot ulcers, b) the precautions patients can take in their daily life, and c) helpful foot gymnastics to be practiced at home. The participants who were randomized in the control group received standard care. Standard care consisted of either physician-prescribed inpatient or outpatient wound care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Nursing counseling

Group Type: EXPERIMENTAL

Nursing counseling

Intervention Type: BEHAVIORAL

The participants who were randomized in the intervention group received outpatient physician-prescribed wound care. Additionally, they received standardized education regarding diabetic foot care. The nurse-led outpatient intervention started a few days after randomization and went on for five weeks. The study nurses conducting the interventions were wound care nurses and trained in foot examination, foot care, education, and counseling. During a period of five weeks, the participants were provided with weekly, one-hour education, skill training, and counseling sessions on foot care. Each participant received a foot care kit with essential foot care material and a foot care diary.

Interventions

Nursing counseling

The participants who were randomized in the intervention group received outpatient physician-prescribed wound care. Additionally, they received standardized education regarding diabetic foot care. The nurse-led outpatient intervention started a few days after randomization and went on for five weeks. The study nurses conducting the interventions were wound care nurses and trained in foot examination, foot care, education, and counseling. During a period of five weeks, the participants were provided with weekly, one-hour education, skill training, and counseling sessions on foot care. Each participant received a foot care kit with essential foot care material and a foot care diary.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• patients age 18 or older with
• current treatment for ulceration and/or amputation of a lower limb
• stable wound healing
• no signs of wound infection
• stable diabetes
• manageable pain

Exclusion Criteria

• patients with cognitive impairment and psychiatric diseases
• patients living in dependent living facilities

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Balgrist University Hospital

OTHER

Sponsor Role: collaborator

Kantonsspital Winterthur KSW

OTHER

Sponsor Role: collaborator

Luzerner Kantonsspital

OTHER

Sponsor Role: collaborator

Kantonsspital Frauenfeld

OTHER

Sponsor Role: collaborator

Spital Zollikerberg

OTHER

Sponsor Role: collaborator

Zurich University of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Lorenz Imhof

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kantonsspital Frauenfeld

Frauenfeld, , Switzerland

Luzerner Kantonsspital

Lucerne, , Switzerland

Kantonsspital Winterthur

Winterthur, , Switzerland

Spital Zollikerberg

Zollikerberg, , Switzerland

Uniklinik Balgrist

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

2010-0278/0

Identifier Type: -

Identifier Source: org_study_id