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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 6 July 2015
Main ID:  ISRCTN55465402
Date of registration: 23/10/2014
Prospective Registration: No
Primary sponsor: The University of Jordan (Jordan)
Public title: The effect of diabetes self efficacy enhancing intervention on diabetes self care management behaviors and psychological wellbeing among Jordanian type two diabetes patients.
Scientific title: The effect of diabetes self efficacy enhancing intervention on diabetes self care management behaviors and psychological wellbeing among Jordanian type two diabetes patients: a randomized clinical trial
Date of first enrolment: 01/05/2014
Target sample size: 168
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN55465402
Study type:  Interventional
Study design:  Randomized controlled trial design (Treatment)  
Phase: 
Countries of recruitment
Jordan
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Zainab    Albikawi
Address:  Amman-Jordan 00962 Amman Jordan
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. Patients should satisfied clinical criteria for DM2 (diabetes type 2)
2. Patient with DM2 who are taking oral agents
3. Patient can be at any stage of their DM diagnosis, length of diagnosis is not a limiting factor in recruitment
4. Patients are required to speak and read Arabic
5. Patients are required to be equal or over the age of 20 years
6. To be eligible for participation in the current study, the patients had to have average score of less than 6.5 out of 8 on DSES
7. Patients are required to have a telephone or mobile in their residence and able to use it effectively

Exclusion criteria: 1. Patients had major complications which would interfere with self-care management behaviors (e.g. legally blind, severe stroke, or undertaking kidney dialysis); patients health records will be checked for the presence of any major DM complications
2. Patients currently managing blood glucose levels with the use of insulin injections alone
3. Patients with cognitive impairment
4. Patients who are not able to communicate
5. Patient with any mental or psychiatric illness, patients health records will be checked for that.


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Type two diabetes mellitis
Nutritional, Metabolic, Endocrine
Intervention(s)
The study intervention is based on self efficacy theory and consists of:
1. DVD, ?Diabetes Self care management? booklets
2. Two rehearsal counseling sessions
3. Follow-up telephone calls
Primary Outcome(s)
Study VariableInstruments:
1. Self ?Efficacy: The Diabetes Self efficacy Scale.
2. Self care management: Summary of Diabetes Self care management Activities (SDSCA), 12 items.
3. Psychological wellbeing: An Arabic version of the Depression Anxiety Stress Scales, DASS-21
4. The Demographic and disease history Questionnaire: Constructed by the current study researcher

The time points for data collection are as the following:screening (pre -intervention or baseline), 2 weeks following screening (post intervention), and 3 months follow up.
Secondary Outcome(s)
Secondary ID(s)
17203
Source(s) of Monetary Support
Investigator initiated and funded (Jordan)
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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