The Effect of The Personalized Patient Engagement Plan on Diabetes Management
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- STATUS
- Recruiting
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- participants needed
- 60
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- sponsor
- Hacettepe University
Summary
This study evaluates the effect of Personalized Patient Engagement Plan on diabetes management in patients with at least six months of Type-2 Diabetes. The research is planned to be carried out as an experimental study with pretest-posttest control groups.
Half of the participants will receive the Personalized Patient Engagement Plan; between two 2 face-to-face sessions including motivational interviews, one telephone coaching call and patient-driven home-based exercises will be conducted. Another half will receive usual care.
Description
Hypotheses
H1-1: Personalized Patient Engagement Plan will significantly affect the self-efficacy of patients with Type-2 Diabetes Mellitus.
H1-2: Personalized Patient Engagement Plan will significantly affect the treatment adherence of patients with Type-2 Diabetes Mellitus.
H1-3: Personalized Patient Engagement Plan will significantly affect the engagement levels of patients with Type-2 Diabetes Mellitus.
- Patients who apply to the Department of Endocrinology Diabetes Education Unit will be evaluated according to the inclusion and exclusion criteria. Health Literacy Scale for Turkish Diabetic Patients will be implemented and patients scoring an average of 2.5 and above will be invited to the study.
- Each patient who accepts the invitation to participate in the study will be assigned a number. In order to assign patients to the intervention and control groups, randomization will be carried out independently of the research via the link https://www.randomizer.org/.
- After randomization is completed and participants are assigned to two groups, the application of the research will be started. In the same session, written informed consent of the relevant Informed Volunteer Consent Form (prepared separately for the intervention and control group) will be obtained.
- After this stage, pre-post tests and defined interventions will be carried out for the intervention group. Control group will only perform pre-post tests and receive usual care. The number of samples is expected to be 60, 30 for the intervention group and 30 for the control group. After these numbers are reached, post power analysis will be done.
Independent variables; demographic characteristics of the patients (age, gender, marital status, employment status, educational status, presence of social security, economic status, place of residence, co-living, diabetes duration, type of treatment received, how long have been treated, experiencing chronic complications related to diabetes condition, acute complications due to diabetes, chronic disease other than diabetes, presence of diabetes disease in the family, monitoring status of blood sugar, regular exercise status, following diabetic diet status, if previously educated about diabetes disease, hospitalization due to diabetes condition, smoking status, alcohol use status, if receiving help to maintain diabetes treatment, and some parameters - body mass index, Hemoglobin A1c, total cholesterol, triglyceride, HDL, LDL, fasting blood sugar and satiety blood sugar) are independent variables.
Statistical analysis will be performed with SPSS 23 (IBM Inc, NY, USA). Correlation and regression will be applied for the mean scores of the scales, the differences between the two groups averages will be analyzed by the significance test of the difference between the two averages, the significance test of the difference between the two percentages, Mann-Whitney U or Chi-Square tests. The level of statistical significance of the study will be p <0.05. Depending on the normality of the data in dependent groups, a comparison will be made with the t-test or Wilcoxon test.
Details
| Condition | NIDDM, Diabetes Mellitus, Patient Compliance, Self Efficacy, Patient Engagement |
|---|---|
| Age | 18years - 65years |
| Treatment | PHEinAction-Personalized Patient Engagement Plan |
| Clinical Study Identifier | NCT04256304 |
| Sponsor | Hacettepe University |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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