Protocol summary

Summary
Present study will be conducted as an interventional study in the form of nonequivalent to compare outcomes between two treatment modalities. In this study we will examine effectiveness and costs associated with adopting / implementing a new policy in Iran: “hospital-based home care”. Study’s sample includes patients with diabetic foot ulcers admitted to a teaching - referral hospital who after being assessed by the researchers are identified to have the inclusion criteria for the study such as decision of the physician to continue therapeutic process at home, having diabetic foot ulcers (based on Wegener classification system for foot wounds in grade 2, 3, 4 and ABI> 0, 5); patient's residency in Tehran, and the patient's consent. Patients who have the criteria are randomly assigned to the control or intervention group. in both groups, outcome indicators of the study include rate of HbA1c, patient's insulin regimen, rate of amputation, wound class, length of stay, patient satisfaction and quality of life. To determine whether two modalities have a significant difference in time of recovery (minimum error of 5%- and - power of 90%), the sample size was determined to include 120 patients, using a systematic sampling technique (30 patients in HBHC and 90 patients HBC). After including patients in the HBHC modality, they are trained about the process and purpose of the study, given an informed consent, introduced to home care providers, discharged from hospital and admitted to the HBHC.

General information

Acronym
Hospital-based home care compared to hospital-based care
IRCT registration information
IRCT registration number: IRCT2017080935600N1
Registration date: 2017-08-15, 1396/05/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-15, 1396/05/24
Registrant information
Name
Mohamadreza Jafary
Name of organization / entity
Tehran uneversity of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2101
Email address
mr-jafary@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ministry of Health and Medical Education; Endocrinology and Metabolism Research Institute
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of hospital-based home care compared to hospital-based care for diabetic foot patients on their quality of life and duration of wound healing in Shariati hospital
Public title
Effectiveness of hospital-based home care compared to hospital-based care for diabetic foot patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the patient has given informed consent to participate within the study; the patient has a primary diagnosis of DF (stage 2,3,4 and ABI >0.5); the patient’s physician must agree that the patient is suitable for early discharge to HBHC; possibility to reside in Tehran, Iran. Exclusion criteria: unstable patient; the patient’s physician order that the patient should be transport to hospital; the patient hasn’t given informed consent.
Age
From 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committe in Resarech afiilated of Endocrinology and Metabolism Research Institute
Street address
Endocrinology and Metabolism Research Institute, Shariati hospital, at the begining of Jalale Al Ahmad avenue, Kargar's north street, Tehran, Iran
City
Tehran
Postal code
1411713137
Approval date
2016-03-02, 1394/12/12
Ethics committee reference number
IR.TUMS.EMRI.REC.1395.0081

Health conditions studied

1

Description of health condition studied
Diabetic Foot Ulcer
ICD-10 code
E10.5
ICD-10 code description
Diabetes mellitus with peripheral circulatory complications

Primary outcomes

1

Description
Duration of wound healing
Timepoint
One mounth after intervention
Method of measurement
Patient interview, screening of medical record

Secondary outcomes

1

Description
Length of stay
Timepoint
18 mounths after intervention
Method of measurement
Screaning of patient record

2

Description
Patient quality of life
Timepoint
18 mounths after intervention
Method of measurement
Patient interview

3

Description
Level of HbA1c
Timepoint
18 mounths after intervention
Method of measurement
Screaning of patient record

4

Description
Rate of patient satisfaction
Timepoint
One mounth after intervention
Method of measurement
patient interview

5

Description
Rate of amputation
Timepoint
18 mounths after intervention
Method of measurement
Patient visit and screening of medical record

Intervention groups

1

Description
Treatment of patients under intervention is continued in their home, having their family support, by a company licensed by Iran’s Ministry of Health, consisting of specialized physician(s) and nurse(s). The patients’ home care process is monitored and controlled by the study group through direct observation in patients home, 2 times a week (according to the timetable of the study). Patients will receive the treatment according to the clinical guidelines for wound management in diabetic foot ulcers approved by the endocrinology and metabolism research center.
Category
Treatment - Other

2

Description
Patients in the control group receive usual care in hospital
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Dr. Mohamadreza Jafary
Street address
Shariati hospital, at the begining of Jalale Al Ahmad avenue, Kargar's north street, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Endocrinology and Metabolism Research Institute
Full name of responsible person
Dr. Mohammad reza Mohajeri
Street address
Endocrinology and Metabolism Research Institute, Shariati hospital, at the begining of Jalale Al Ahmad avenue, Kargar's north street, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrinology and Metabolism Research Institute
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zhila Najafpour
Position
PhD Health Care Managment
Other areas of specialty/work
Street address
Economic And Health Management group, Public Health Faculty, Tehran University of Medical Sciences, Pour Sina street, Keshavarz boulevard, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8490 2101
Fax
Email
zh-najafpour@razi.tums.ac.ir; zhila.najafpoor@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shariati Hospital
Full name of responsible person
Dr. Mohamadreza Jafary
Position
General practitionar
Other areas of specialty/work
Street address
Shariati hospital, at the begining of Jalale Al Ahmad avenue, Kargar's north street, Tehran, Iran
City
Tehran
Postal code
1411713137
Phone
+98 21 8490 2101
Fax
+98 21 8822 0042
Email
mrezajafary@yahoo.com, mr-jafary@farabi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shariati Hospital
Full name of responsible person
Dr. Mohamadreza Jafary
Position
General practitionar
Other areas of specialty/work
Street address
Shariati hospital, at the begining of Jalale Al Ahmad avenue, Kargar's north street, Tehran, Iran
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2101
Fax
Email
mrezajafary@yahoo.com; mr-jafari@farabi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...