Assessing the effectiveness of Health Complex interventional model in comparison with routine health system on comprehensive health management performance indicators in East Azerbaijan: Field Trial
(1) Objectives:
Assessing the effectiveness of Health Complex on performance indicators of health system
(2) Design:
Intervention and control groups
300 clusters of 20 households
Multi center
No Randomization and No Blinding
(3) Setting and conduct:
Data will gathered with specific questionnaires before and 2 years after intervention
(4) Participants including major eligibility criteria:
Households will be selected and in households the persons greater than 18 years will be studied.
(5) Intervention:
Foundation of Health Complex
(6) Main outcome measures (primary and secondary outcome variables):
Health services utilization
Trust to health system
Responsiveness
Self-care
Customer satisfaction
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402112150N3
Registration date:2016-01-10, 1394/10/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-10, 1394/10/20
Registrant information
Name
Homayoun Sadeghi Bazargani
Name of organization / entity
Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 3741
Email address
homayoun.sadeghi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice Chancellor of Tabriz University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effectiveness of Health Complex interventional model in comparison with routine health system on comprehensive health management performance indicators in East Azerbaijan: Field Trial
Public title
Assessing the effectiveness of Health Complex on performance indicators of health system
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion Criteria :
1.Marginalized Population of Tabriz
2.greater than 18 years
Exclusion Criteria :
1. Lack of consent
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
6000
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht Ave
City
Tabriz
Postal code
Approval date
2015-04-27, 1394/02/07
Ethics committee reference number
TBZMED.REC.1394.35
Health conditions studied
1
Description of health condition studied
Diabetes Type 2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
2
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode
3
Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
self care
Timepoint
before intervention , 2 years after intervention
Method of measurement
General Selfcare Questionnaire
2
Description
Responsiveness
Timepoint
before intervention , 2 years after intervention
Method of measurement
Questionnaire
3
Description
Health Services Utilization
Timepoint
before intervention , 2 years after intervention
Method of measurement
Questionnaire
4
Description
Trust to Health System
Timepoint
before intervention , 2 years after intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Customer Satisfaction
Timepoint
before intervention,2 years after intervention
Method of measurement
Questionnaire
2
Description
Staff Satisfaction
Timepoint
before intervention,2 years after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
foundation of health complex :
Health Complex is an accountable and responsive health care organization to deliver an integrated care services to people in a defined catchment area against identified per capita payment, under district health center policies and regulations .
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Health Center
Full name of responsible person
Dr Oroumchi
Street address
Tabriz-Akhmagayeh
City
Tabriz
2
Recruitment center
Name of recruitment center
Azadi Health Center
Full name of responsible person
Mr Alizadeh
Street address
Tabriz - Mofatteh Ave
City
Tabriz
3
Recruitment center
Name of recruitment center
Emamyeh Health Center
Full name of responsible person
Dr Vahdati
Street address
Tabriz - Emamyeh
City
Tabriz
4
Recruitment center
Name of recruitment center
Sahand Chamran Health Center
Full name of responsible person
Mrs Safari
Street address
Tabriz - Sahand
City
Oskou
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Rashidi
Street address
Golghasht Ave
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Mostafa Farahbakhsh
Position
Psychiatrist
Other areas of specialty/work
Street address
Seghat ol Eslam Ave
City
Tabriz
Postal code
Phone
+98 41 3233 0147
Fax
+98 41 3233 0196
Email
mfarahbakhsh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
health faculty
Full name of responsible person
Homayoun Sadeghi Bazargani
Position
epidemiologist
Other areas of specialty/work
Street address
Attar Nishaboori Ave
City
Tabriz
Postal code
Phone
+98 41 3334 0308
Fax
Email
homayoun.sadeghi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mostafa Farahbakhsh
Position
Psychiatrist
Other areas of specialty/work
Street address
Seghat ol Eslam Ave
City
Tabriz
Postal code
Phone
+98 41 3233 0147
Fax
+98 41 3233 0196
Email
mfarahbakhsh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)