Determination of implementation of Nurse-led Care on Quality of Care and healing of diabetic foot ulcer
Design
Randomized clinical trial
Settings and conduct
The purpose of the research will be explained to patients with diabetic foot ulcer that referred to Shariati hospital and written consent will be obtained. Then 20 subjects for each group were selected according to the sample size formula and divided into two groups (intervention: nursing-led and control: routine care), before and after intervention and follow-up (6 weeks and 12 weeks after intervention) Diabetic Foot Ulcer checklist and QUALPAC (Quality Patient Care Scale) questionnaire will be completed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with type 1 diabetes and two diagnosed men and women 18 years of age and older diabetic patients with foot ulcer
Exclusive criteria: Patients with active foot ulcer Patients participate in similar studies
Intervention groups
Nurse-led group: Nurse-led interventions will be done with Integrated, Interdisciplinary and Comprehensive Steps. In the Integrated phase, care delivery will be step by step and according to Guideline of care for diabetic foot ulcer. In the interdisciplinary phase, the counseling required by the treatment team will be carried out. In the Comprehensive phase, supportive and education care services will be transferred to the patient and their caregiver depending on the patient's need.
Control group: The control group will be treated and provided routinely care which include control of blood sugar, appropriate antibiotic treatment if it was necessary, off loading foot ulcer, remove the foot ulcer and dressing with saline normal.
Main outcome variables
Quality of care, Remove of Diabetic foot ulcer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100628004256N8
Registration date:2018-11-13, 1397/08/22
Registration timing:registered_while_recruiting
Last update:2018-11-13, 1397/08/22
Update count:0
Registration date
2018-11-13, 1397/08/22
Registrant information
Name
Nasrin Samadi
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1551 3057
Email address
na.samadi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2019-10-07, 1398/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Implementation of Nurse-led Care on Quality of Care and healing of diabetic foot ulcer
Public title
Implementation of Nurse-led Care on Quality of Care and healing of diabetic foot ulcer
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
patients with type 1 diabetes and two diagnosed
men and women 18 years of age and older
diabetic patients with foot ulcer
Exclusion criteria:
Patients with active foot ulcer( presence of secretions at the site of the ulcer, has an infectious smell, yellow or white ulcer)
Patients participate in similar studies
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
Quality of care, measure Diabetic foot ulcer
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher will do the random assignment by blocking and using the card. Considering that 40 people should be included in the study and there will be two groups (navigator nurses and control group), taking into account all possible probabilities, 20 blocks of 6 states will be calculated.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
There is not more attribution.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Eastern Nosrat st, Tohid esquare,Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
5619835164
Approval date
2018-02-17, 1396/11/28
Ethics committee reference number
IR.TUMS.FNM.REC.1396.4526
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Quality of care
Timepoint
Before intervention, 6 weeks after intervention and follow up 12 weeks after the intervention
Method of measurement
(Quality Patient Care Scale) QUALPAC
Secondary outcomes
1
Description
Healing of Diabetic foot ulcer
Timepoint
Before intervention/6 weeks after intervention And follow up 12 weeks after the intervention
Method of measurement
Wound Assessment Check list
Intervention groups
1
Description
Intervention group: Nurse-led interventions will be done with Integrated, Interdisciplinary and Comprehensive Steps. In the Integrated phase, care delivery will be step by step and in accordance with the Guideline, care for diabetic foot ulcer. In the interdisciplinary phase, the counseling required by the treatment team will be carried out. In the Comprehensive phase, supportive and educative as a care services will be provided to the patient and their caregiver depending on the patient's need.
Category
Treatment - Other
2
Description
Control group: The control group will be treated and provided routinely care which include control of blood sugar, appropriate antibiotic treatment if it was necessary, off loading, remove of foot ulcer and dressing with saline normal.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics and educational hospitals under the supervision of Tehran University of Medical Sciences
Full name of responsible person
Research Deputy
Street address
Eastern Nosreat st, Tohid esquare,Tehran,Iran.
City
Tehran
Province
Tehran
Postal code
5619835164
Phone
+98 21 6692 5560
Email
nasrin.samadi87@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Research Deputy of school of Nursing and Midwifery
Street address
Eastern Nosreat st, Tohid square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
5619835164
Phone
+98 21 6692 5560
Email
nasrin.samadi87@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nasrin Samadi
Position
Academic Staff
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Eastern Nosreat st, Tohid square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
5619835164
Phone
+98 21 6692 5560
Email
nasrin.samadi87@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nasrin Samadi
Position
Academic Staff
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Eastern Nosreat st, Tohid square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
5619835164
Phone
+98 21 6692 5560
Email
nasrin.samadi87@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nasrin Samadi
Position
Academic Staff
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Eastern Nosreat st, Tohid square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
5619835164
Phone
+98 21 6692 5560
Email
nasrin.samadi87@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available