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Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration

Primary Purpose

Diabetic Foot Ulcer

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Nursing counseling
Sponsored by
Zurich University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Foot Ulcer focused on measuring Diabetes, Nursing counseling, Foot ulceration, Outpatient, Advanced Practice Nurse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients age 18 or older
  • in current treatment for ulceration and/or amputation of a lower limb
  • are able to understand German oral and in writing
  • are able to give written informed consent

Exclusion Criteria:

  • severe psychiatric diagnoses
  • subjects living in dependent living facilities (nursing home or rehabilitation)
  • subjects lacking supporting family members and incapable of selfmonitoring their feet due to impairment (vision or physical movement)

Sites / Locations

  • Zurich University of Applied SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard care

Nursing counseling

Arm Description

All participants receive three specially-developed brochures with information regarding the diabetic foot condition. The brochures containes 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 are randomized in the intervention group receive standardized education regarding diabetic foot care. The nurse-led outpatient intervention go on for five weeks. During a period of five weeks, the participants are provided with weekly education, skill training, and counseling sessions on foot care.

Outcomes

Primary Outcome Measures

Effectiveness of nurse-led intervention for high risk patients with diabetic foot ulceration/amputation
After the baseline data collection (T0), data will be collected after 5 weeks (T1), 12 weeks (T2), 24 weeks (T3) and after 42 weeks (T4) regarding: - foot related complications (hospital readmission for ulceration recurrence, new ulcerations or amputations)

Secondary Outcome Measures

Full Information

First Posted
March 3, 2014
Last Updated
January 23, 2015
Sponsor
Zurich University of Applied Sciences
Collaborators
Swiss National Science Foundation, Nursing Science Foundation Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT02086955
Brief Title
Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration
Official Title
Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zurich University of Applied Sciences
Collaborators
Swiss National Science Foundation, Nursing Science Foundation Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to evaluate the effectiveness of a nurse led intervention for high risk patients with diabetic foot ulceration and/or amputation. The effectiveness is defined in two ways 1) as a reduction in complication rates (time till ulceration recurrence, new ulcerations, amputation or reamputation) and 2) as a reduction in hospital readmissions for foot-related complication (one year survival probability: failure = readmission for ulceration recurrence, new ulcerations, amputation or re-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. 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. The 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
Diabetes, Nursing counseling, Foot ulceration, Outpatient, Advanced Practice Nurse

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
No Intervention
Arm Description
All participants receive three specially-developed brochures with information regarding the diabetic foot condition. The brochures containes 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.
Arm Title
Nursing counseling
Arm Type
Experimental
Arm Description
The participants who are randomized in the intervention group receive standardized education regarding diabetic foot care. The nurse-led outpatient intervention go on for five weeks. During a period of five weeks, the participants are provided with weekly education, skill training, and counseling sessions on foot care.
Intervention Type
Behavioral
Intervention Name(s)
Nursing counseling
Intervention Description
The participants who are randomized in the intervention group receive standardized education regarding diabetic foot care. The nurse-led outpatient intervention lasts five weeks. During a period of five weeks, the participants are provided with weekly skill training, and counseling sessions on foot care. Each participant receives a foot care kit with essential foot care material and a foot care diary.
Primary Outcome Measure Information:
Title
Effectiveness of nurse-led intervention for high risk patients with diabetic foot ulceration/amputation
Description
After the baseline data collection (T0), data will be collected after 5 weeks (T1), 12 weeks (T2), 24 weeks (T3) and after 42 weeks (T4) regarding: - foot related complications (hospital readmission for ulceration recurrence, new ulcerations or amputations)
Time Frame
Participants will be followed for the duration of 42 weeks. Data will be collected at baseline (T0) as well as after 5 weeks (T1), 12 weeks (T2), 24 weeks (T3) and after 42 weeks (T4).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients age 18 or older in current treatment for ulceration and/or amputation of a lower limb are able to understand German oral and in writing are able to give written informed consent Exclusion Criteria: severe psychiatric diagnoses subjects living in dependent living facilities (nursing home or rehabilitation) subjects lacking supporting family members and incapable of selfmonitoring their feet due to impairment (vision or physical movement)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lorenz Imhof, Prof. Dr.
Phone
0041589346333
Email
lorenz.imhof@zhaw.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorenz Imhof, Prof. Dr.
Organizational Affiliation
University of applied sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zurich University of Applied Sciences
City
Winterthur
State/Province
Zurich
ZIP/Postal Code
8400
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorenz Imhof, Prf. Dr.
Phone
++41 (0)58 934 63 33
Email
lorenz.imhof@zhaw.ch

12. IPD Sharing Statement

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Outpatient Nurse Managed Counseling Program for Patients With Diabetic Foot Ulceration

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