Comparison of the effectiveness of educaional intrervention based Adult Learning Theory- with and without telephone follow up by nurse(telenursing) on self-management in adult with Epilepsy
This Randomized Controlled Trial (RCT)was conducted to Comparison of the effectiveness of educational intrervention based on Adult Learning Theory with and without telephone fallow up by nurse (Telenursing) on self-management in adult with Epilepsy. Epileptic patient who had 18 years old and elder and met other inclusion criteria from Isfahan Society of Epilepsy were recruited. 120 adults with epilepsy were recruited then were randomly assigned to the 3 groups؛1)Those in the education group received a four-session education based on Adult Learning Theory,2)Those in the education &Telephone follow up group received a four session education based on Adult Learning Theory plus 6 session telephone follow up by nurse and 3)Those in control group received no intervention.. Education session- based on principle of Adult Learning Theory- held for groups 1 and 2(1-hour once per week for 4 consecutive weeks). After the training sessions, nurse call with the participants in the second group in the certain intervals (total 6 phone contacts). For all participants had completed the Epilepsy Self-Management Scale and demographic information at the baseline and 4months after by the researcher.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012121511758N1
Registration date:2013-01-05, 1391/10/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-05, 1391/10/16
Registrant information
Name
Elham Bagheri BaghAbrishami
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 66927171
Email address
e.bagheri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Reseach of Tehran University of Medical Science
Expected recruitment start date
2012-07-29, 1391/05/08
Expected recruitment end date
2012-08-29, 1391/06/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of educaional intrervention based Adult Learning Theory- with and without telephone follow up by nurse(telenursing) on self-management in adult with Epilepsy
Public title
Comparison effectiveness of educaion and telenursing on self-management in adult with Epilepsy
Purpose
Supportive
Inclusion/Exclusion criteria
Individuals were eligible if they had been diagnosed of epilepsy by a neurologist, diagnosed with epilepsy for at least 6 months; were receiving antiepileptic drugs (AEDs); were 18 years old and elder ; were able to understand and speak Persian ; had a telephone (or access to one).Residents in Isfahan and its surrounding.
Exclusion criteria:
Unwilling to participate in Clinical Trial
Hospitalized for any reason during the training sessions
Non participate in any of education session (in education and education plus telephone follow up groups)
- No answer to 2 or more phone contacts(in education plus telephone follow up group)
Age
From 18 years old to 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Science
Street address
Tehran University of Medical Science, Tehran, Iran
City
Tehran
Postal code
Approval date
2012-07-29, 1391/05/08
Ethics committee reference number
1008/130/ص/91
Health conditions studied
1
Description of health condition studied
Localization-related (focal)(partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset
ICD-10 code
G40.0
ICD-10 code description
Incl.: Benign childhood epilepsy with centrotemporal EEG spikes- Childhood epilepsy with occipital EEG paroxysms
2
Description of health condition studied
Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures
ICD-10 code
G40.1
ICD-10 code description
Incl.: Attacks without alteration of consciousness- Simple partial seizures developing into secondarily generalized seizures
3
Description of health condition studied
Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures
ICD-10 code
G40.2
ICD-10 code description
Incl.: Attacks with alteration of consciousness, often with automatisms- Complex partial seizures developing into secondarily generalized seizures
4
Description of health condition studied
Generalized idiopathic epilepsy and epileptic syndromes
ICD-10 code
G40.3
ICD-10 code description
Incl.:Benign: myoclonic epilepsy in infancy- neonatal convulsions (familial)- Childhood absence epilepsy [pyknolepsy]- Epilepsy with grand mal seizures on awakening- Juvenile: absence epilepsy- myoclonic epilepsy [impulsive petit mal]- Nonspecific epilept
5
Description of health condition studied
Other generalized epilepsy and epileptic syndromes
ICD-10 code
G40.4
ICD-10 code description
Incl.:Epilepsy with: myoclonic absences- myoclonic-astatic seizures- Infantile spasms- Lennox-Gastaut syndrome-Salaam attacks- Symptomatic early myoclonic encephalopathy- West syndrome
6
Description of health condition studied
Special epileptic syndromes
ICD-10 code
G40.5
ICD-10 code description
Incl.: Epilepsia partialis continua [Kozhevnikof]- Epileptic seizures related to: alcohol, drugs, hormonal changes, sleep deprivation, stress
7
Description of health condition studied
Grand mal seizures, unspecified (with or without petit mal)
ICD-10 code
G40.6
ICD-10 code description
8
Description of health condition studied
Petit mal, unspecified, without grand mal seizures
ICD-10 code
G40.7
ICD-10 code description
9
Description of health condition studied
Other epilepsy
ICD-10 code
G40.8
ICD-10 code description
Incl.: Epilepsies and epileptic syndromes undetermined as to whether they are focal or generalized
10
Description of health condition studied
Epilepsy, unspecified
ICD-10 code
G40.9
ICD-10 code description
Incl.: Epileptic: convulsions NOS- fits NOS- seizures NOS
Primary outcomes
1
Description
Epilepsy self-management
Timepoint
At baseline - 4months after
Method of measurement
Epilepsy Self-Management Scale(ESMS)
Secondary outcomes
1
Description
Age
Timepoint
At baseline
Method of measurement
Demographic information
2
Description
Gender
Timepoint
At baseline
Method of measurement
Demographic information
3
Description
Education level
Timepoint
At baseline
Method of measurement
Demographic information
4
Description
Marital status
Timepoint
At baseline
Method of measurement
Demographic information
5
Description
Occupation
Timepoint
At baseline
Method of measurement
Demographic information
6
Description
Economic status
Timepoint
At baseline
Method of measurement
Demographic information
7
Description
Insurance
Timepoint
At baseline
Method of measurement
Demographic information
8
Description
Duration of disease
Timepoint
At baseline
Method of measurement
Demographic information
9
Description
Type of seizure
Timepoint
At baseline
Method of measurement
Demographic information
10
Description
Number of Antiepileptic Drugs
Timepoint
At baseline
Method of measurement
Demographic information
11
Description
Frequency of seizure
Timepoint
At baseline
Method of measurement
Demographic information
12
Description
Other disease
Timepoint
At baseline
Method of measurement
Demographic information
Intervention groups
1
Description
Education based on Adult Learning Theory - The education program was developed to be delivered in a group discussion for approximately 10–12 individuals, meeting for a 1-hour once per week for 4 consecutive .The curriculum included a mixture of psychosocial and medical information topics framed in the self-management activities.The overriding theme of self-management was built into all sessions, session materials, and session discussions. For example, meeting 1 focused on information management, Topics that were discussed in detail focused on definition of epilepsy, type of seizure, diagnosis and treatment. Other discussed topic was medication management (such as maintaining blood levels of medications, side effects, drug toxicity identification), seizure triggers and life style management, including sleep, exercise, stress, smoking and other risky behaviors, safety management, psychosocial factors such as depression, stigma, occupation, marriage, social interaction and etc. We also solicited input from the group participants on each topic throughout the discussion and encouraged sharing of personal histories, experiences, perspectives, and approaches to self-management. Group leaders helped to identify the self-management strategies used by participants in real-life scenarios.
Category
Other
2
Description
Education based on Adult Learning Theory plus Telephone Follow up by Nurse - The education program was developed to be de 1-hourblock of time once per week for 4 consecutive weeks. The curriculum included a mixture of psychosocial and medical information topics framed in the self-management activities.The overriding theme of self-management was built into all sessions, session materials, and session discussions. For example, meeting 1 focused on information management. Topics that were discussed in detail focused on definition of epilepsy, type of seizure, diagnosis and treatment. Other discussed topic was medication management (such as maintaining blood levels of medications, side effects, drug toxicity identification), seizure triggers and life style management, including sleep, exercise, stress, smoking and other risky behaviors, safety management, psychosocial factors such as depression, stigma, occupation, marriage, social interaction and etc. We also solicited input from the group participants on each topic throughout the discussion and encouraged sharing of personal histories, experiences, perspectives, and approaches to self-management. Group leaders helped to identify the self-managementstrategies used by participants in real-life scenarios.
This session was followed by six telephone- based on sessions content over the next 2 months (first month weekly and second month every 2 week) aimed at enhancing self-management practices in thefollowing areas: medication, information, seizure, safety, and lifestyle. For each of the phone contact, the nurses first discussed medication management with the participant.The nurse began by asking a general question about medication-taking practices. Participants who were taking medications as prescribed and had no difficulties were encouraged to continue with their regimen. Those who reported problems with medications(e.g., nonadherence or side effects) were provided supportin weighing the costs and benefits of adherence, eliciting barriersto adherence and supporting efforts to solve the barriers to adherence. Following the discussion of medications, the nurse asked the participant to select one or two other self-management components that were important to him or her. The subsequent discussion was directed toward identifying barriers and facilitators of desired behaviors(e.g., reducing stress). Participants were encouraged to develop their own solutions and devise an action plan.
Category
Other
3
Description
The participants enrolled in the control group received no intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Society of Epilepsy
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Reseach of Tehran University of Medical Science
Full name of responsible person
Dr Masud Yunesisn
Street address
Sixth Floor, Central Organization of TUMS, Keshavarz Blvd, Tehran, Iran
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 Reseach of Tehran University of Medical Science
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
Tehran university of medical sience
Full name of responsible person
Elham Bagheri Baghabrishami
Position
Nursing Student of Master of Sience
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
elsa.1384@yahoo.co
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Zahra Rahnavard
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
zahra.rahnavard@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Elham Bagheri Baghabrishami
Position
Nursing Student of Master of Sience
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery,Tehran University of Medical Sciences,Nosrat St.,Tohid Sq,Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
elsa.1384@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)