Clinical trial NCT01731808: Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration: a Pilot Study
Official title: Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Nursing counseling
diabetic foot
Lead sponsor: Zurich University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Balgrist University Hospital
name: Kantonsspital Winterthur KSW
name: Luzerner Kantonsspital
name: Kantonsspital Frauenfeld
name: Spital Zollikerberg
First posted: 2012-11-22
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

Primary outcomes:
measure: feasibility of an intensive nurse led education program
timeFrame: The outcome measures will be assessed after all recruited participants have completed the five week education program - at the latest two years after study start.
Secondary outcomes:
Other outcomes:
Locations:
city: Frauenfeld
country: Switzerland
facility: Kantonsspital Frauenfeld
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zollikerberg
country: Switzerland
facility: Spital Zollikerberg
city: Zurich
country: Switzerland
facility: Uniklinik Balgrist
Study officials:
References: