Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06345196 |
| Other study ID # |
BozokUni |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2024 |
| Est. completion date |
October 15, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Bozok University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will be conducted using a randomized controlled trial design to evaluate the
effect of online individual motivational interviewing on well-being, stress and difficulties
in individuals with diabetes. The study will be conducted between March 2024 and March 2025
with individuals with Type 2 Diabetes who are followed up in Yozgat Bozok University Health
Practice and Research Center Internal Medicine Polyclinic. The motivational interview group
will receive a motivational interview once a week, lasting a maximum of 40 minutes,
consisting of a total of four sessions. Chi-square (X2), t-test, repeated measures analysis
of variance, Pearson correlation coefficient, partial eta-square and linear regression
analysis will be used to evaluate the data.
Description:
Approximately 537 million people worldwide have diabetes and it is estimated to reach 643
million in 2030 and 783 million in 2045. In this context, the prevalence of diabetes is
increasing and 1.5 million people die each year due to diabetes. Diabetes is a chronic
disease that requires complex care activities and multiple decision-making related to
self-management. In particular, the most common is type 2 diabetes in adults, which occurs
when the body becomes resistant to insulin or does not produce enough insulin. Daily
self-management of the disease is necessary for individuals with type 2 diabetes to achieve
healthy glucose levels, minimize the effects of the disease on their daily lives and reduce
the risk of developing complications. The main elements of self-management in individuals
with diabetes include taking medication, maintaining a healthy diet, regular physical
activity, foot care and monitoring blood glucose for insulin users.
Managing diabetes is a process that requires continuous effort and adherence to multiple
health behaviors, and many patients have difficulty managing this chronic condition. This
situation increases stress in individuals and causes deterioration in well-being and
psychosocial status.
Stress in individuals with diabetes can negatively affect problem-solving skills and lead to
poor self-management behavior. However, it has also been reported that positive well-being in
individuals with diabetes has a good effect on disease management (better glucose control,
reduced disease burden, increased work productivity and reduced mortality). However,
individuals with type 2 diabetes have been found to have lower well-being than the general
population. Therefore, it is important to develop stress coping strategies and support
positive well-being for people with diabetes.
The control of diabetes depends on the individual's healthy lifestyle behaviors and disease
management as well as the pharmacological treatment option. However, many systematic reviews
show that motivational interviewing is an effective intervention method in the treatment of
diabetes. These studies have shown that it has positive effects on diet and weight
management, diabetes self-management, medication adherence, and glycemic control in
individuals with diabetes. Looking at the literature, although less stress and positive
well-being are important to overcome the difficulties in disease management in individuals
with diabetes, studies on supporting stress and positive well-being in type 2 diabetes
patients are limited. In this context, this study will be conducted to determine the effect
of motivational interviewing applied to individuals with diabetes on well-being, stress and
difficulties.
