Protocol summary

Summary
The aim of this clinical trial study is to determine of the impact of collaborative care model on care burden and resilience of family caregivers of mentally ill patients. Among the study population consist of family caregivers of mentally ill patients who hospitalize in Shahid Rajaiee mental Hospital of Yasuj, 64 families will select and the caregivers have a main role in care giving and their score of care burden questionnaires will at least 47 will enrolled the study. After the introduction of the researcher and explanation about objectives of the study, the informed consent is obtained. Then researcher applied for need assessment of these families and following, demographic questionnaire, Novak and Guest’s care burden questionnaire (1989) and Sixbey’s family resilience assessment scale (2005) were completed by objects. The test group divided to groups contain 8 to 10 families and educational plan based on data analysis of the first stage (pre- intervention) will be conducted on experimental group whereas the control group will not receive any training at this time. This educational program led to the identification of resource, needs and weaknesses in different dimension and include 4 levels of motivation, preparation, engagement and evaluation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015060622580N1
Registration date: 2015-07-31, 1394/05/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-07-31, 1394/05/09
Registrant information
Name
Mohammad Zoladl
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3334 6978
Email address
zoladl.mohammad@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research and technology of Yasuj University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2015-06-19, 1394/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of collaborative care model on care burden and resilience of family caregivers of mentally ill patients
Public title
Impact of collaborative care on care burden and resilience
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age range of 15 to 75 years old; have literacy in educational status; have a main role in care giving; have not any diagnosed mental illness; the score of family care burden questionnaires will at least 47; completion of written informed consent and exclusion criteria will : Withdraw from the study when the research objects want ; lack of cooperation ; incomplete returned questionnaires; Immigration; no appropriate participation in training sessions after entering the study
Age
From 15 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
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
Yasuj University of Medical Sciences
Street address
Deputy of research and technology, Yasuj University of Medical Science, Shahid Motahari Blvd., Yasuj, Iran
City
Yasuj
Postal code
Approval date
2015-02-22, 1393/12/03
Ethics committee reference number
9301200312

Health conditions studied

1

Description of health condition studied
Family care burden in families of mental ill paient
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Care burden
Timepoint
At the begining of study
Method of measurement
Novak and Guest care-giver burden inventory-1989

2

Description
Resillience
Timepoint
At the begining of study
Method of measurement
Sixbeyfamily resillience questionnaire-2005

Secondary outcomes

1

Description
Care burden
Timepoint
A month after manipulation (collaborative care model)
Method of measurement
Novak and Guest care-giver burden inventory-1989

2

Description
Resillience
Timepoint
A month after manipulation (collaborative care model)
Method of measurement
Sixbey family resillience questionnaire-2005

Intervention groups

1

Description
Collaborative care model in experimental group
Category
Behavior

2

Description
No manipulation but they will give Routine care
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rajaiee Hospital
Full name of responsible person
Street address
Shahid Rajaiee Hospital, Imam Hossein Square, Yasuj, Iran
City
Yasuj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of research and technology of Yasuj University of Medical Sciences
Full name of responsible person
Dr. Mehdi Akbartabar Touri
Street address
Research manager office, Deputy of research and technology, Yasuj University of Medical Science, Shahid Motahari Blvd, Yasuj, Iran
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research and technology of Yasuj 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Dr. Mohammad Zoladl
Position
PhD of psychiatric nursing- Associate Professor
Other areas of specialty/work
Street address
Faulty of nursing and midwifery of Yasuj University of Medical Science, Shahid Dr.Jalil Street, Yasuj, Iran
City
Yasuj
Postal code
Phone
+98 74 3323 5141
Fax
Email
zoladl.mohammad@yums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Aminollah Haghgoo
Position
Ms student of Psychiatric nursing
Other areas of specialty/work
Street address
Faulty of nursing and midwifery of Yasuj University of Medical Science, Shahid Dr.Jalil Street, Yasuj, Iran
City
Yasuj
Postal code
Phone
+98 74 3323 5141
Fax
Email
amin.haghgoo65@gmail.com
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...