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
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|
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, 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
Experimental: Intervention group
Personalized Health Engagement Plan group
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
- 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.
- 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).
- 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.
- 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.
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
|Contact: Dilara Usta, MScfirstname.lastname@example.org|
|Study Director:||Fatoş Korkmaz, Assoc. Prof.||Hacettepe University|