Clinical Trial: Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration: a Pilot Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration: a Pilot Study
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 Summary:
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 c
Sponsor: Zurich University of Applied Sciences
Current Primary Outcome: feasibility of an intensive nurse led education program [ Time Frame: 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. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Zurich University of Applied Sciences
Dates:
Date Received: October 18, 2012
Date Started: October 2010
Date Completion:
Last Updated: March 3, 2014
Last Verified: March 2014
