Type 2 DiabetesNCT04256304
The Effect of The Personalized Patient Engagement Plan on Diabetes Management
A study testing PHEinAction-Personalized Patient Engagement Plan in people with Type 2 Diabetes and Patient Engagement, run by Hacettepe University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Patient Engagement, Self Efficacy
- What is being tested?
- PHEinAction-Personalized Patient Engagement Plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 28 Dec 2018to 29 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- being unable to take responsibility for self-care
- pregnancy/planning pregnancy
- severe thinking or mental problems (diagnosed psychiatric disorders).
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Hacettepe University Faculty of Nursing
Ankara
Hacettepe University
Ankara
About this study
Official title: The Effect of The Personalized Patient Engagement Plan on Diabetes Management in Patients With Type 2 Diabetes
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.
Read the 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.
- 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).
- 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.
- 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/.
- 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
- Being tested
- PHEinAction-Personalized Patient Engagement Plan
- Medical subject headings
- Diabetes Mellitus, Type 2, Patient Participation, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHEinAction-Personalized Patient Engagement PlanBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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 Receives: Behavioral: PHEinAction-Personalized Patient Engagement Plan |
| Control group | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start28 Dec 2018
- Primary completion29 Nov 2021
- Study completion29 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Dilara Usta, Hacettepe University
- Investigators
- Fatoş Korkmaz, Assoc. Prof., Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256304
- Sponsor's protocol ID
- Ka-19031
- Status last verified
- Nov 2022
- First submitted
- 3 Feb 2020
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for all outcome measures will be available.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of The Personalized Patient Engagement Plan on Diabetes Management in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04256304
- Acronym / sponsor ID
- Ka-19031
- Conditions
- Type 2 Diabetes, Patient Engagement, Self Efficacy, Adherence, Patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 28 Dec 2018 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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).
- 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.
- 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/.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: PHEinAction-Personalized Patient Engagement PlanPersonalized 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 |
| Control group | No intervention | –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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- being unable to take responsibility for self-care
- pregnancy/planning pregnancy
- severe thinking or mental problems (diagnosed psychiatric disorders).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PHEinAction-Personalized Patient Engagement PlanThe 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. | Behavioural | Intervention group |
Primary outcome
Patient Health Engagement Scale
Time frame: 1 month
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: 1 month
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: 1 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- Individual participant dataSharing planned: Yes. IPD for all outcome measures will be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatoş Korkmaz, Assoc. Prof. study director
Hacettepe University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHEinAction-Personalized Patient Engagement Plan in people with Type 2 Diabetes and Patient Engagement, run by Hacettepe University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Engagement Scale (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2022.