The Effect of The Personalized Patient Engagement Plan on Diabetes Management

NCT ID: NCT04256304

Last Updated: 2022-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-28
• Study Completion Date: 2021-11-29

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.

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.

Conditions

Type 2 Diabetes; Patient Engagement; Self Efficacy; Adherence, Patient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Personalized Health Engagement Plan group

1. First face-to-face session (Motivational interviewing) + Pre-tests

• Patient Health Engagement Scale
• Assessment Scale for Treatment Adherence in Type 2 Diabetes Mellitus
• The Diabetes Management Self-Efficacy Scale for Patients with Type 2 Diabetes Mellitus

2. Phone call coaching

3. A set of personalized home-based exercises

4. Second face-to-face session (Motivational interviewing) + Post-tests

Group Type: EXPERIMENTAL

PHEinAction-Personalized Patient Engagement Plan

Intervention Type: BEHAVIORAL

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.

Control group

1. First meeting (Pre-tests)

• Patient Health Engagement Scale
• Assessment Scale for Treatment Adherence in Type 2 Diabetes Mellitus
• The Diabetes Management Self-Efficacy Scale for Patients with Type 2 Diabetes Mellitus

2. Second meeting (Post-tests)

• Patient Health Engagement Scale
• Assessment Scale for Treatment Adherence in Type 2 Diabetes Mellitus
• The Diabetes Management Self-Efficacy Scale for Patients with Type 2 Diabetes Mellitus

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PHEinAction-Personalized Patient Engagement Plan

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• having type 2 diabetes for at least six months
• receiving medication for type 2 diabetes
• ability to speak, read, write and understand Turkish
• to score an average of 2.5 points on the Health Literacy Scale

Exclusion Criteria

• being unable to take responsibility for self-care
• pregnancy/planning pregnancy
• severe thinking or mental problems (diagnosed psychiatric disorders).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Dilara Usta

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatoş Korkmaz, Assoc. Prof.

Role: STUDY_DIRECTOR

Hacettepe University

Locations

Hacettepe University Faculty of Nursing

Ankara, , Turkey (Türkiye)

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Ka-19031

Identifier Type: -

Identifier Source: org_study_id