Plain English Summary
Background and study aims
Type 2 diabetes is a long-term condition where the body doesnt produce enough insulin to function properly or, alternatively, the cells of the body dont react well to insulin. This can cause blood sugar levels to become too high and, if left untreated, can lead to a number of health problems including heart disease, stroke, kidney disease, eyesight problems and nerve damage. People with type 2 diabetes have to look after their health very carefully. This includes eating a healthy diet, taking regular exercise, limiting the amount of alcohol they drink and making sure that they know when to seek medical attention for any health concerns that they may have. Here, we want to test a new self-help programme (diabetes self-efficacy enhancing intervention) for people who have type 2 diabetes. We want to see if the intervention leads to improvements in patients feeling more confident about managing their condition, psychological wellbeing and self-care management behaviours.
Who can participate?
Jordanian patients aged at least 20 years, diagnosed with type 2 diabetes and being treated at the diabetes specialized centre in Amman-Jordan.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) receive their usual care and the new diabetes self-efficacy enhancing intervention. Those in group 2 (control group) receive their usual care. The intervention consists of watching a DVD, diabetes self-care management booklets, two counselling sessions and follow-up telephone calls.
What are the possible benefits and risks of participating?
There are several potential benefits to this study.. The intervention is designed to help people self-manage their disease and maintain a healthy lifestyle, solve problems and make an action plan. Risks are minimal. Patients displaying psychological stress will be informed by the researcher to stop participating in the trial.
Where is the study run from?
The University of Jordan (Jordan)
When is the study starting and how long is it expected to run for?
May 2014 to December 2014.
Who is funding the study?
Investigator initiated and funded (Jordon)
Who is the main contact?
Mrs Zainab Albikawi
zainbikawi@gmail.com
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17203
Study information
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
Acronym
Study hypothesis
1. Patients who participated in diabetes self efficacy enhancing intervention (DSEEIP) had higher levels of DM (diabetes mellitis) self care management behaviors following completion of the DSEEIP at 10 weeks post-intervention, and at a three month post-intervention follow-up evaluation, than who did not receive the intervention.
2. Patients who participated in diabetes self efficacy enhancing intervention (DSEEIP) had higher levels of DM self-efficacy following completion of the DSEEIP at 2 weeks post-intervention, and at a three month post-intervention follow-up evaluation, than who did not receive the intervention.
3. Patients who participated in diabetes self efficacy enhancing intervention (DSEEIP) will have higher levels of psychological wellbeing following completion of the DSEEIP at 2 weeks post-intervention, and at a three month post-intervention follow-up evaluation, than who did not receive the intervention
3.1. Additional Question
Are there differences in the control and intervention group baseline scores for the three outcome variables based on the demographic and disease history data?
Ethics approval
University of Jordon Ethical Committee, December 2013
Study design
Randomized controlled trial design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Demographic data sheet
Condition
Type two diabetes mellitis
Intervention
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
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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 measures
N/A
Overall trial start date
01/05/2014
Overall trial end date
01/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
168
Participant 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.
Recruitment start date
01/05/2014
Recruitment end date
01/12/2014
Locations
Countries of recruitment
Jordan
Trial participating centre
Amman-Jordan
Amman
00962
Jordan
Funders
Funder type
Other
Funder name
Investigator initiated and funded (Jordan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list