The effect of diabetes self efficacy enhancing intervention on diabetes self care management behaviors and psychological wellbeing among Jordanian type two diabetes patients.

ISRCTN ISRCTN55465402
DOI https://doi.org/10.1186/ISRCTN55465402
Secondary identifying numbers 17203
Submission date
25/04/2014
Registration date
23/10/2014
Last edited
20/01/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Type 2 diabetes is a long-term condition where the body doesn’t produce enough insulin to function properly or, alternatively, the cells of the body don’t 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

Contact information

Mrs Zainab Albikawi
Scientific

Amman-Jordan
Amman
00962
Jordan

Study information

Study designRandomized controlled trial design
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Demographic data sheet
Scientific titleThe 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
Study objectives1. 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(s)University of Jordon Ethical Committee, December 2013
Health condition(s) or problem(s) studiedType two diabetes mellitis
InterventionThe 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 typeOther
Primary outcome measureStudy 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 measuresN/A
Overall study start date01/05/2014
Completion date01/12/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants168
Key inclusion criteria1. 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
Key exclusion criteria1. 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.
Date of first enrolment01/05/2014
Date of final enrolment01/12/2014

Locations

Countries of recruitment

  • Jordan

Study participating centre

Amman-Jordan
Amman
00962
Jordan

Sponsor information

The University of Jordan (Jordan)
University/education

c/o Zainab Albikawi
Amman
11942
Jordan

ROR logo "ROR" https://ror.org/05k89ew48

Funders

Funder type

Other

Investigator initiated and funded (Jordan)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan