The Effect of The Personalized Patient Engagement Plan on Diabetes Management
Condition: Type 2 Diabetes; Patient Engagement; Self Efficacy; Adherence, Patient
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

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.
    

Intervention name(s): PHEinAction-Personalized Patient Engagement Plan
Intervention type(s): Behavioral
Intervention description(s): The intervention includes two face-to-face sessions, a telephone consultation, and written home-based exercises. The first session aims to promote an awareness of patients with diabetes management, define an action plan to encourage engagement, introduce the patient to follow their strategy for the next four weeks, and encourage them to adopt the instruments with home-based exercises to reach their specified health goals. Two weeks after the first interview session, the researcher will provide telephone consultation to check the patient for their progress and support them to maintain motivation. The second session will include collecting patient's experiences and discussing the home-based exercises, re-determining the patient health engagement phase through the PHE-s®, discussing the personalized care goals by providing feedback aiming to support improvements, and setting a new engagement goal with the current status and encouraging the patient to maintain the health engagement plan.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care