NCT04256304|CompletedDMC
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Sponsor study identifier
interventional
59
1 country
2
Study Start
December 28, 2018
Actual (reported)Primary Completion
November 29, 2021
Actual (reported)Study Completion
November 29, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 29, 2021
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 28, 2018
Actual (reported)February 3, 2020
Actual (reported)February 5, 2020
Actual (reported)November 29, 2021
Actual (reported)November 29, 2021
Actual (reported)Patient Health Engagement Scale
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.
1 month
Assessment Scale for Treatment Adherence in Type 2 Diabetes Mellitus
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).
Health Literacy Scale for Turkish Diabetic Patients
1 month
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
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hacettepe University Faculty of Nursing
Ankara, Turkey (Türkiye)
Hacettepe University
Ankara, Turkey (Türkiye)
Fatoş Korkmaz, Assoc. Prof.
Hacettepe University
59 participants (actual enrollment reported by the registry).
First Submitted
February 3, 2020
First Posted
February 5, 2020
Study Start
December 28, 2018
Actual (reported)1 month
The Diabetes Management Self-Efficacy Scale for Patients with Type 2 Diabetes Mellitus
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.
1 month
Contact the study team to confirm eligibility.
Primary Completion
November 29, 2021
Actual (reported)Study Completion
November 29, 2021
Actual (reported)Last Updated
November 28, 2022
Record last verified: 2022-11
IPD for all outcome measures will be available.
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Source: ClinicalTrials.gov.
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