Effect of cooperative caregiver training versus individual training on the adherence to treatment in patients with heart failure: a randomized clinical trial
Objectives: To assess the effect of cooperative primary caregiver training versus individual training on the adherence to treatment in patients with heart failure
Design: a randomized clinical trial.
Setting and conduct: The eligible patients with heart failure who will refer to Ekbatan Clinic during the study period will be enrolled into the trial.
Inclusion criteria: (a) having heart failure class 2 or 3; (b) ability to read and write; (c) cooperation of one the patient's family member as the main caregiver.
Exclusion criteria: (a) having congenital heart disease; (b) history of heart surgery; (c) living alone; (d) severe physical disability; (e) history of participating in similar training and rehabilitation class.
Intervention group: Six one-hour training sessions during 2 weeks for patients and their caregivers.
Control group: Six one-hour training sessions during 2 weeks only for patients.
Primary outcome: Assessing the adherence to treatment 6 weeks after intervention using adherence to treatment questionnaire.
Secondary outcome: Nothing.
Randomization: Random assignment of the patients to the intervention and control groups using random number table.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201511209014N84
Registration date:2015-11-27, 1394/09/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-27, 1394/09/06
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2015-09-06, 1394/06/15
Expected recruitment end date
2016-02-04, 1394/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of cooperative caregiver training versus individual training on the adherence to treatment in patients with heart failure: a randomized clinical trial
Public title
Effect of cooperative caregiver training versus individual training on the adherence to treatment in patients with heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: (a) having heart failure class 2 or 3; (b) ability to read and write; (c) cooperation of one the patient's family member as the main caregiver.
Exclusion criteria: (a) having congenital heart disease; (b) history of heart surgery; (c) living alone; (d) severe physical disability; (e) history of participating in similar training and rehabilitation class.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups using random number table.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2015-08-17, 1394/05/26
Ethics committee reference number
IR.UMSHA.REC.1394.250
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Assessing the adherence to treatment
Timepoint
6 weeks after intervention
Method of measurement
using adherence to treatment questionnaire
Secondary outcomes
1
Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing
Intervention groups
1
Description
Six one-hour training sessions during 2 weeks for patients and their caregivers
Category
Other
2
Description
Six one-hour training sessions during 2 weeks only for patients
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ekbatan Clinic
Full name of responsible person
Zahra Ghanbari Azarm
Street address
Ekbatan Clinic, Taleghani Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Ekbatan Clinic
Full name of responsible person
Zahra Ghanbari Azarm
Position
Nursing Student
Other areas of specialty/work
Street address
Ekbatan Clinic, Taleghani Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0447
Fax
Email
ghanbariazarm64@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ekbatan Clinic
Full name of responsible person
Gholam Hossein Falahinia
Position
MSc in Nursing
Other areas of specialty/work
Street address
Ekbatan Clinic, Taleghani Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0447
Fax
Email
falahinia@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)