Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05544435 |
| Other study ID # |
ETÜ--ULUDAG---001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 25, 2019 |
| Est. completion date |
May 30, 2020 |
Study information
| Verified date |
September 2022 |
| Source |
Erzurum Technical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Purpose:This study aims to research the effects of motivational interviewing on self-care
activities in patients with type 2 diabetes.
Design and Method:This study is a quasi-experimental clinical research with pre-test
post-test comparison.12 sessions were held in 3 months in the experimental group with
motivational interviewing method.
Findings:After a 3-month follow up, while a significant improvement was observed in
post-intervention self-care activities in the experimental group, a significant decrease was
observed in all self-care activities except foot care in the control group.
Practice Implications:Motivational interviewing intervention can be used to develop self-care
activities in type 2 diabetes patients, especially to guide diabetes nurses.
Description:
This study is a quasi-experimental clinical research with pre-test post-test comparison.
Population of the study consists of patients who referred to internal medicine outpatient
clinic and clinics of a state hospital and who were diagnosed with T2DM between September
2019 and May 2020. The study was initiated with 60 patients who were aged 18 and older,
diagnosed with T2DM at least 6 months ago, literate, living in city centre and with a HbA1c
value of 6.5% or higher. These patients were described as potential participants by the
researchers and experimental (30 patients) and control (30 patients) groups were formed by
using simple random numbers table. The participants were explained about the aim of the study
and oral and written permissions were taken. During the study period, 6 patients in the
experimental group and 3 patients in the control group left the study for various reasons and
the study was ended with 51 patients. In data collection, patient information form prepared
by the researchers (age, gender, marital status, educational status, disease duration,
presence of another chronic disease and smoking status), metabolic variable values (HbA1c and
fasting blood sugar) and Summary of diabetes self-care activities scale (SDSCA) developed by
Toobert and Glaskow (1994) and revised in 2000 (D.J. Toobert et al., 2000) were used. Summary
of diabetes self-care activities scale consists of subscales such as patient diet, exercise,
blood sugar test, foot care and smoking. As a result of the calculation of scores, high
scores indicate that patients can fulfil self-care behaviors. After the initial data were
collected, the patients in the experimental group were given appointments by the researcher
for MI intervention. No intervention was performed on the control group participants and they
were given appointment for post-test application three months later.
2.1. Intervention In addition to the care they always received, MI sessions were conducted by
the researcher for the participants in the experimental group. This intervention was
conducted as 30-45 minutes of 12 sessions in total for each patient for a period of 3 months
by the academic nurse. In these sessions, the agenda was created in accordance with the
nature of MI intervention, efforts were made to resolve the ambivalent feelings in the
patient, the patient's change phase was determined, the patient's self-confidence for change
was determined, it was questioned how much the patient cared for change and the patient was
helped in determining the change plan. In addition, during the sessions, the problems
patients experienced about self-care activities, the causes of these problems and the
barriers in maintaining self-care activities were discussed and efforts were made to create
awareness in patients.
In each MI session;
- Opening and structuring; Meeting, information was given about our role and goals in the
study, how much time the investigators have, the role of the counselee and about there
will be detailed questions during the study and the session was opened with the question
What is on your mind?'
- Creating agenda: What are the investigators going to talk about today? (What would
participants like to talk about today, having your blood sugar measured, eating
healthily, getting your medication or exercising/Maybe there is something else?)
- Decision balance: Conflict was created in individuals by asking them to compare their
existing healthcare behaviors and ideal/desired healthcare behaviors.
- Determining significance and confidence: How important is it for participants to fulfil
self-care activities? How much confidence do participants have in yourself about this?
- Change plan: After decision balance was established, its suitability for patients was
evaluated, at the end of the session, an action (change) plan was created for the
desired behavior change and the session was closed by determining the next interview
day-hour.
In the last MI session:
- The session was opened by summarizing the previous interview.
- A general discussion was made on change.
- Individuals' self-care activities were evaluated (The Summary of Diabetes Self-Care)
- Appointment was made from the hospital for individuals to have their glycemic values
measured and the values were recorded (glycemic laboratory results).
- Closing.