The effect of family caregiver-oriented discharge planning program on nutritional status, laboratory nutritional parameters and quality of life in patient suffering from hip fractures
This study is a clinical trial includes two groups in order to defining the effect of family caregiver-oriented discharge planning program on nutritional status, laboratory nutritional parameters and quality of life in patient suffering from hip fractures. The study population includes All patients with the diagnosing of intertrochanteric hip fracture hospitalized in an orthopedic departments of Imam Khomeini hospital in Tehran with their family caregivers. Inclusion criteria: age of 18 years or older; hip fracture detection of intertrochanter, discharge to home (specific to nursing homes or care centers ... not reference); having at least one caregiver (the patient does not live alone it has to be watched). Exclusion criteria: multiple fractures or other pathological malignant and malignant diseases; irreversible phase of illness; seeking discharge against medical advice; create any type of trauma and serious illness after discharge to 6 months. Allocating patients in the two groups will done randomly on the basis of six blocks. According to volume formula, the number of samples needed in each group is 42 persons and 84 patients will determine totally. All participants signed an informed consent. Before intervention demographic questionnaire, nutritional status questionnaire (MNA), measuring laboratory nutritional parameters (albumin, total protein and TLC) as well as quality of life questionnaire (EQ-5D-5L) will be completed in both groups. control groups will receive the routine care by hospital personnel, but the intervention group will receive the family caregiver-oriented discharge planning. The discharge planning will start from hospitalization and will continue for 6 month after discharging. 6 weeks after discharge laboratory nutritional parameters, 3 months and 6 months after discharge and nutritional status and laboratory nutritional parameters and quality of life of these patients are re-evaluated. Also, six months after discharge, mortality, readmission and fall will be measured in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016072119141N2
Registration date:2016-09-30, 1395/07/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-30, 1395/07/09
Registrant information
Name
Hooman Shahsavari
Name of organization / entity
The faculty of Nursing and Midwifery of Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4319
Email address
h_shahsavari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family caregiver-oriented discharge planning program on nutritional status, laboratory nutritional parameters and quality of life in patient suffering from hip fractures
Public title
The effect of family caregiver-oriented discharge planning program on nutritional status, laboratory nutritional parameters and quality of life in patient suffering from hip fractures
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 18 years or older; hip fracture detection of intertrochanter, discharge to home (specific to nursing homes or care centers ... not reference); having at least one caregiver (the patient does not live alone it has to be watched).
Exclusion criteria: multiple fractures or other pathological malignant and malignant diseases; irreversible phase of illness; seeking discharge against medical advice; create any type of trauma and serious illness after discharge to 6 months
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
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
Ethicsl Commitee of Tehran Faculty of Nursing and Midwifery and rehabilitation
Street address
Faculty of Nursing and Midwifery, Nosrat Sharghi Street, Tohid Square, Tehran Tehran
City
Tehran
Postal code
Approval date
2016-08-31, 1395/06/10
Ethics committee reference number
IR.TUMS.FNM.REC.1395.531
Health conditions studied
1
Description of health condition studied
Hip fracture
ICD-10 code
S72.1
ICD-10 code description
Pertrochanteric fracture
Primary outcomes
1
Description
Nutritional status
Timepoint
Before intervention, 3 and 6 months after intervention
Before intervention, 3 and 6 months after intervention
Method of measurement
Lab sampling
3
Description
Quality of life
Timepoint
Before intervention, 3 and 6 months after intervention
Method of measurement
Quality of life questionnaire (EQ-5D-5L)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the discharge planning will start from the time of patient hospitalization and continue for 6 month after discharging. The stages of performing discharge planning are: This group will receive a training booklet includes training fractures, symptoms, complications and treatment, limitation of activity, education, exercise programs, adaptive techniques to perform daily activities, nutritional advice, use of mobility aids, self care, care wounds, medications, complications, health care follow-up time in addition to the individual face to face training in the postoperative period during the three sessions, each session lasting 1 hour based on patient preference in terms of timing. The researcher will call each of the patients once two weeks for 6 month after discharging to problems raised and check the patient improved, reaching to the aims and adherence the trail planning. The researchers throughout the week by the phone is available for patients and family caregivers. During the phone calls necessary arrangements to meet with the patient in the clinic 6 weeks, 3 months and 6 months after discharge will will be told.
Category
Other
2
Description
Control group: patients in the control group will receive the same routine training from nurses in Orthopedic units.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Sahar malehmir
Street address
Imam Khomeini Hospital, Keshavarz Blvd., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masood Younesian
Street address
Central building of Tehran University of Medical Sciences, Qhds street, Keshavarz Blvd.
City
Tehran
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
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
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Sahar Malehmir
Position
Master of Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Nosrat Sharghi Street, Tohid Square, Tehran
City
Tehran
Postal code
Phone
+98 216633309193
Fax
Email
saharmalmir93@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Dr. Hooman Shahsavari
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Nosrat Sharghi Street, Tohid Square
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
h_shahsavari@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery,Tehran University of Medical Sciences
Full name of responsible person
Sahar Malehmir
Position
Master of Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Nosrat Sharghi Street, Tohid square
City
Tehran
Postal code
Phone
+98 21 6633 3091
Fax
Email
saharmalmir93@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)