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The Effect of The Personalized Patient Engagement Plan on Diabetes Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04256304
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Dilara Usta, Hacettepe University

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Patient Engagement Self Efficacy Adherence, Patient Behavioral: PHEinAction-Personalized Patient Engagement Plan Not Applicable

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 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.
  2. 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/.
  3. 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.
  4. 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, if receiving help to continue 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of The Personalized Patient Engagement Plan on Diabetes Management in Patients With Type 2 Diabetes
Actual Study Start Date : December 28, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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

    • 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
Behavioral: PHEinAction-Personalized Patient Engagement Plan

The intervention includes two face-to-face motivational interviewing. The first interview aims to promote an awareness of patients with Type 2 diabetes management, to define an action plan to encourage engagement, to sustain motivation to provide a proactive role in diabetes self-management. After the assessment of patient engagement level (using patient health engagement scale), patients will be encouraged to set engagement goals.

After the first session, patients will complete home-based paper-pen exercises comprising 12 components (3 exercises, one emotional, one cognitive, and one behavioural; for every of the four engagement levels).

Two weeks after the first interview, a brief telephone-based coaching encounter will be performed to check the difficulties and to maintain the motivation of the patients.

Then, a second session will be performed to assess the whole process, to share the experiences and assessment results, to reinforce the positive changes.


No Intervention: 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



Primary Outcome Measures :
  1. Patient Health Engagement Scale [ Time Frame: 2 days ]
    The Patient Health Engagement Scale (PHE-s) is an instrument assessing the engagement of patients in their care process and was developed in 2015 (Ordinal α=0,85). The PHE-s was developed based on the four-stage model of patient engagement (blackout, arousal, adhesion, and eudaimonic project), has an ordinal nature, and it consists of 5 items with seven responses, which allow patients' to reflect their experience about their care. In scoring, points 1 and 2 refer to the blackout, 3 and 4 to the arousal, 5 and 6 to the adhesion, and finally, point 7 refers to the eudaimonic phase. The median value is regarded while calculating the final PHE-s score. The Turkish validity study was conducted in 2019. The content validity index (CVI) was 0.98, and the Ordinal alpha was 0.80.

  2. Assessment Scale for Treatment Adherence in Type 2 Diabetes Mellitus [ Time Frame: 2 days ]
    The treatment adherence was assessed using the Assessment Scale for Treatment Adherence in Type 2 Diabetes Mellitus developed in 2017 for Turkish patients with diabetes, and Cronbach α was found to be 0,77. The scale consists of a total of 30 items and has a 5-point Likert structure (certainly agree=1, I agree=2, I partially agree=3, I do not agree=4, certainly do not agree=5). The highest score is 150 while the lowest score is 30. If the total score is between 30-54, it is considered as "good adherence"; if it is between 55-125, it is assessed "moderate adherence" and finally scores between 126-150 indicates "poor adherence" to the treatment. The scale consists of 7 sub-dimensions (emotional difficulties in compliance, physical difficulties in compliance, changing difficulties of habits in compliance, acceptance difficulties in compliance, awareness difficulties in compliance, diet difficulties in compliance, and denial difficulties in compliance).

  3. The Diabetes Management Self‐Efficacy Scale for Patients with Type 2 Diabetes Mellitus [ Time Frame: 2 days ]
    The Self Effectiveness Scale for Diabetes Management in Type 2 Diabetes Patients was developed in 1999 to determine the level of self-efficacy they have during their care for diabetes patients.


Other Outcome Measures:
  1. Health Literacy Scale for Turkish Diabetic Patients [ Time Frame: 1 day ]
    Health Literacy Scale (HLS) for Turkish Diabetic Patients will be used for randomisation. The original HLS is comprised of three subscales to assess the functional (five items), interactive (five items), and critical (four items) health literacy of diabetes patients. The results of Turkish psychometric evaluation showed that the overall Cronbach's alpha for HLS was 0.96, and for functional, interactive and critical subscales were 0.96, 0.91, and 0.96, respectively, and S-CVI was 0.97. Higher scores in communicative and critical HL indicates higher HL, but the scores were reversed for the functional subscale.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • having Type-2 Diabetes at least 6 months
  • having a diabetes education at least once in the last 6 months
  • having insulin or/and oral antidiabetic drug treatment
  • being able to understand, read, speak, and write in Turkish
  • Scoring an average of 2.5 points on the Health Literacy Scale for Turkish Diabetic Patients.

Exclusion Criteria:

  • being unable to take responsibility for self-care
  • refuse to participate in the study
  • having a psychiatric diagnosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04256304


Contacts
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Contact: Dilara Usta, MSc +905536252891 dilarausta6@gmail.com

Locations
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Turkey
Hacettepe University Faculty of Nursing Recruiting
Ankara, Turkey
Contact: Dilara Usta, MSc    +905536252891    dilarausta6@gmail.com   
Hacettepe University Recruiting
Ankara, Turkey
Contact: Fatoş Korkmaz, Assoc. Prof.    +905074486409    korkmazfatos@gmail.com   
Sponsors and Collaborators
Hacettepe University
Investigators
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Study Director: Fatoş Korkmaz, Assoc. Prof. Hacettepe University

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Responsible Party: Dilara Usta, Research Assistant, Hacettepe University
ClinicalTrials.gov Identifier: NCT04256304    
Other Study ID Numbers: Ka-19031
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for all outcome measures will be available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data will be available within 6 months of study completion.
Access Criteria: Requestors will be required to sign a Data Access Agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases