Clinical trial NCT06973954: Improving the Activation Level of Diabetic Individuals
Official title: Determination of Variables Associated With the Activation Level of Diabetic Individuals and Improvement of Activation Level
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus (DM)
Type 2 Diabetes Mellitus (T2DM)
Patient Activation
Diabetes Self-management
Keywords: Diabetes Mellitus
Type 2 Diabetes Mellitus
Patient Activation
Patient Activation İnterventions
Improving Patient Activation
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a randomized controlled study planned in two stages: descriptive and experimental. In the first descriptive stage, variables related to the activation level of diabetic viruses were determined. Data were collected from 151 diabetic individuals. The second experimental planned stage was conducted on 30 individuals in the experimental group and 30 individuals in the control group, determined by randomization from 151 diabetic individuals whose data were collected in the first stage.
Primary purpose: OTHER

Brief summary: This study was planned to determine the activation levels of diabetic individuals and to improve the activation level. The study, planned as a descriptive and experimental type, is an attempt to increase the activation level of diabetic individuals.

Detailed description: Type 2 diabetes, which is rapidly increasing in prevalence worldwide and poses a global threat, is a complex, chronic condition that requires ongoing medical care with multifactorial risk reduction strategies in addition to glucose management. 1 It causes serious physical and psychological distress to patients and their families, and also imposes a heavy economic burden on society. "2, 3, 4 Therefore, treatment of type 2 diabetes and prevention of its complications are particularly important. Self-management is the key to effective management and control of diabetes. 2, 5 Self-management, which includes activities such as diet, physical activity, self-monitoring of blood sugar, foot care, adherence to medication, and prevention of complications in managing symptoms and lifestyle changes associated with type 2 diabetes , is considered the cornerstone of diabetes management. "2, 6, 7, 8, 9, 10, 11" Individuals with chronic diseases such as type 2 diabetes need to participate in health care services to achieve better self-management and better health outcomes. The basis for this is patient activation. Patient activation refers to the knowledge, skills, and confidence of an individual in managing their own health and health care. Patient activation is the driving force of self-management. 12 Literature shows that individuals with high activation levels use more self-management services, exhibit better self-management behaviors such as diet, physical activity, and adherence to treatment plans, and tend to show optimal clinical outcomes such as HbA1c, high-density lipoproteins (HDL), blood pressure, and triglycerides. "2, 8, 12, 13, 14" In addition, more active adult patients believe they are in control of their own health. 17, 18 Highly activation patients show greater self-efficacy, higher quality of life, and lower depression scores. "17, 19, 21, 22, 23, 24, 25" Patients who demonstrate low levels of activation are often apathetic and depressed, have low health-related knowledge, low goal orientation, and poor compliance with any preventive health regimen or treatment, viewing their health as the responsibility of their physicians .

Positive health outcomes obtained with increased patient activation have led researchers to work on activating individuals. Studies examining the factors associated with activation in diabetic individuals are limited. Based on the data obtained from these studies, factors associated with patient activation have been grouped under three headings: demographic, clinical, and psychosocial factors. Demographic factors associated with patient activation have been reported in the literature as age, level of education, gender, race, marital status, and income status. In clinical factors, healthy nutrition, regular exercise, regular health screening, better diabetes control, body mass index, and positive health perception have been found to be associated with patient activation. Psychosocial factors associated with patient activation have been reported as health literacy, patient satisfaction, quality of life, level of hope, negative disease perception, self-efficacy, and depression.

Despite this evidence, there is insufficient literature on the determinants of patient activation in developing countries like ours. The aim of our study is to determine the variables associated with activation in individuals with type 2 diabetes.

Eligibility criteria: Inclusion Criteria:

Having diabetes for 1 year or more, Able to read and write Turkish, Having no visual, auditory, perceptual or any other physical disability, Having the physical, mental and emotional capacity to participate in self-care activities, Having no language problems, Accepting to participate voluntarily in the study.

Exclusion Criteria:

* Individuals with any mental/cognitive problems,

  * Those who cannot read or write,
  * Those with visual, hearing, perception or any physical disability,
  * Those who are immobile or bedridden,
  * Those who do not have the ability to participate in their own self-care activities,
  * Those who do not want to participate in the study were excluded from the sample.

Primary outcomes:
measure: Patient Activation Measure
timeFrame: 6 months
measure: Patient Activation Level
timeFrame: 6 months
Secondary outcomes:
measure: Self-care Behaviors, Metabolic Control Values, Self-Effectiveness Level
timeFrame: 6 months
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University Health Sciences Institute Izmir
Study officials:
affiliation: Dokuz Eylul University Faculty of Nursing
name: Dilek Büyükkaya Besen, Associate professor
role: STUDY_DIRECTOR
References: