Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-24 @ 9:06 PM
Study NCT ID:
NCT04256304
Status:
COMPLETED
Last Update Posted:
2022-11-28
First Post:
2020-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of The Personalized Patient Engagement Plan on Diabetes Management
Sponsor:
Hacettepe University
Organization:
Study Overview
Official Title:
The Effect of The Personalized Patient Engagement Plan on Diabetes Management in Patients With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed 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.
1. Patients who apply to the endocrine outpatient unit will be evaluated according to the inclusion and exclusion criteria. At first, the RA will obtain a daily list of patients waiting for their appointment with the endocrinologist each day of the recruitment period and will access the medical records of waiting patients and screen for the eligibility criteria. Patients meeting the eligibility criteria will be invited to a room located in the outpatient clinic and be asked to fill out Health Literacy Scale (HSL).
2. After the final eligibility assessment, the potential participants will be provided information regarding the study's objectives and be asked for their written informed consent. The researcher will collect consented participants' telephone numbers to determine their next endocrinologist appointment and collect the baseline data, including the sociodemographic and diabetes-related characteristics, laboratory HbA1c testing, body mass index (BMI), and the measures of treatment compliance, self-efficacy, and patient engagement.
3. Each participant 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/.
4. After randomization is completed and participants are assigned to two groups, the application of the research will start. After this stage, defined interventions will be carried out for the intervention group. The 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, a 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.
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.
1. Patients who apply to the endocrine outpatient unit will be evaluated according to the inclusion and exclusion criteria. At first, the RA will obtain a daily list of patients waiting for their appointment with the endocrinologist each day of the recruitment period and will access the medical records of waiting patients and screen for the eligibility criteria. Patients meeting the eligibility criteria will be invited to a room located in the outpatient clinic and be asked to fill out Health Literacy Scale (HSL).
2. After the final eligibility assessment, the potential participants will be provided information regarding the study's objectives and be asked for their written informed consent. The researcher will collect consented participants' telephone numbers to determine their next endocrinologist appointment and collect the baseline data, including the sociodemographic and diabetes-related characteristics, laboratory HbA1c testing, body mass index (BMI), and the measures of treatment compliance, self-efficacy, and patient engagement.
3. Each participant 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/.
4. After randomization is completed and participants are assigned to two groups, the application of the research will start. After this stage, defined interventions will be carried out for the intervention group. The 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, a 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: