The purpose of the study is to determine the effect of cognitive - behavioral therapy on adherence and remove of related barriers in hemodialysis patients. This study is a clinical trial and will be done on 70 hemodialysis patients who will be admitted in hemodialysis wards of Lar and Lamerd hospitals. Inclusion criteria: Having writing and reading abilities and scoring less than 50 on adherence to treatment with patient consent. Exclusion criteria: Not willing to continue the study. The patients randomly are allocated in intervention and control groups.
In the intervention group: cognitive - behavioral therapy will be carried out in six stages consist of: identifying patient's problem, creating self confidence and commitment to patient, improving awareness of the behavior; making a good plan, evaluating of training plan and maintaining behavioral changes. In the control group without any intervention adherence and barriers questionnaires will be completed again 3 months later.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211101599N21
Registration date:2013-05-12, 1392/02/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-05-12, 1392/02/22
Registrant information
Name
Mitra Zolfaghari
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
zolfaghm@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Science
Expected recruitment start date
2013-05-30, 1392/03/09
Expected recruitment end date
2013-09-19, 1392/06/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive-behavioral intervention on adherence to therapeutic regimen and remove of related barriers in hemodialysis patients
Public title
Improving adherence to therapeutic regimen in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 20-60 years old hemodialysis patients who are on hemodialysis for at least one year 2 or 3 times a week, each session lasting 4-3 hours. Hemodialysis should be able to read and write in research subjects and Score less than 50 on adherence to treatment. Exclusion criteria: Not willing to continue participating in the study .Not attending any of the educational intervention
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Two hospitals in Lar and Lamerd will be randomly assigned to the cognitive - behavioral intervention and control groups. These hospitals have equal aspects for hemodialysis and have similar nursing performance. 70 hemodialysis patients who will be admitted in hemodialysis wards of Lar and Lamerd hospitals will be participated in this study by convenience sampling.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee-Tehran University of Medical Sciences
Street address
Ghods St. Keshavarz Blv. Central building of Tehran University of Medical Sciences, 6th floor
City
Tehran
Postal code
Approval date
2013-01-07, 1391/10/18
Ethics committee reference number
2527/130/1
Health conditions studied
1
Description of health condition studied
Chronic renal disease
ICD-10 code
N18.5
ICD-10 code description
Chronic uremia
Primary outcomes
1
Description
Adherence to therapeutic regimen
Timepoint
Before the intervention, and three months after intervention
Method of measurement
A researcher-made questionnaire with likert scale
Secondary outcomes
1
Description
Barriers of adherence to therapeutic regimen
Timepoint
Before the intervention, and three months after intervention
Method of measurement
A researcher-made questionnaire with likert scale
Intervention groups
1
Description
Cognitive-behavioral intervention consist of six steps: Step 1: Identifying the problem. In This step, Knowledge, belief, and the barrier to self-care will be determined by person-to-person interviews. Step 2: Creating confidence and commitment. In This step, the patient and the researcher will be signed a contract to begin working on a particular behavior change after face-to-face counseling. Step 3: Increasing awareness of behavior. This step leads to increase in the patient’s awareness of his or her behavior patterns through self-monitoring. The subjects were asked to keep a diary of adherence every day until the next consultation. Step 4: Developing and implementing the action plan. Based on the subject’s behavior, statements in the diary of adherence, a short-term action plan (On an individual basis), will be designed by researcher. Step 5: Evaluating the plan is designed. Impact on behavior change plan will be evaluated. If the subject failed, a new plan that can be achieved will be designed. Step 6: Maintain the desired behavior change to prevent undesirable behavior. The purpose of this step is to maintain and reinforce desired behaviors through motivational phrases.
Category
Treatment - Other
2
Description
Control group with no intervention adherence rates and barriers to adherence to treatment is evaluated before and 3 months after
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Street address
Doctor Dadman High Way. Lar. New Town.
City
Larestan
2
Recruitment center
Name of recruitment center
Hospital Lamerd
Full name of responsible person
Street address
Lamerd City. Hospital Lamerd
City
Lamerd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences. Ghods St. Keshavarz Bv.
City
Tehran
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, 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
Nursing and Midwifery College
Full name of responsible person
Sookhak Fatemeh
Position
Master of Science Critical Care Nursing
Other areas of specialty/work
Street address
Tohied Sq. Nosrat St. Nursing and Midwifery School.
City
Tehran
Postal code
Phone
+98 21 6105 4402
Fax
Email
Sookhakfatemeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mitra Zolfaghari
Position
PhD.
Other areas of specialty/work
Street address
Virtual School of Tehran University of Medical Sciences.
City
Tehran
Postal code
Phone
+98 21 8896 9594
Fax
Email
zolfaghm@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing and Midwifery College of Tehran University of Medical Sciences.
Full name of responsible person
Sookhak Fatemeh
Position
Master of Science Critical Care Nursing
Other areas of specialty/work
Street address
No:27, Vahdat St. Larestan
City
Lar
Postal code
Phone
+98 21 6105 4402
Fax
Email
Sookhakfatemeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)