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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:
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ISRCTN |
Last refreshed on:
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6 July 2015 |
Main ID: |
ISRCTN55465402 |
Date of registration:
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23/10/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The effect of diabetes self efficacy enhancing intervention on diabetes self care management behaviors and psychological wellbeing among Jordanian type two diabetes patients.
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Scientific title:
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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:
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01/05/2014 |
Target sample size:
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168 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN55465402 |
Study type:
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Interventional |
Study design:
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Randomized controlled trial design (Treatment)
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Phase:
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Countries of recruitment
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Jordan
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Zainab
Albikawi |
Address:
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Amman-Jordan
00962
Amman
Jordan |
Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Type two diabetes mellitis Nutritional, Metabolic, Endocrine
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Intervention(s)
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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
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Primary Outcome(s)
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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.
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Source(s) of Monetary Support
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Investigator initiated and funded (Jordan)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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