Diabetes Mellitus (DM)NCT06973954
Improving the Activation Level of Diabetic Individuals
A study testing Text Message Intervention in people with Diabetes Mellitus (DM) and Type 2 Diabetes Mellitus (T2DM), run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to determine the activation levels of diabetic individuals and to improve the activation level. The study, planned as a descriptive and experimental type, is an attempt to increase the activation level of diabetic individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus (DM), Type 2 Diabetes Mellitus (T2DM), Patient Activation
- What is being tested?
- Text Message Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2025to 25 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having diabetes for 1 year or more, Able to read and write Turkish, Having no visual, auditory, perceptual or any other physical disability, Having the physical, mental and emotional capacity to participate in self-care activities, Having no language problems, Accepting to participate voluntarily in the study.
Who cannot join
- Individuals with any mental/cognitive problems,
- Those who cannot read or write,
- Those with visual, hearing, perception or any physical disability,
- Those who are immobile or bedridden,
- Those who do not have the ability to participate in their own self-care activities,
- Those who do not want to participate in the study were excluded from the sample.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylul University Health Sciences Institute Izmir
Izmir
About this study
Official title: Determination of Variables Associated With the Activation Level of Diabetic Individuals and Improvement of Activation Level
This study was planned to determine the activation levels of diabetic individuals and to improve the activation level. The study, planned as a descriptive and experimental type, is an attempt to increase the activation level of diabetic individuals.
Read the detailed description
Type 2 diabetes, which is rapidly increasing in prevalence worldwide and poses a global threat, is a complex, chronic condition that requires ongoing medical care with multifactorial risk reduction strategies in addition to glucose management. 1 It causes serious physical and psychological distress to patients and their families, and also imposes a heavy economic burden on society. "2, 3, 4 Therefore, treatment of type 2 diabetes and prevention of its complications are particularly important. Self-management is the key to effective management and control of diabetes. 2, 5 Self-management, which includes activities such as diet, physical activity, self-monitoring of blood sugar, foot care, adherence to medication, and prevention of complications in managing symptoms and lifestyle changes associated with type 2 diabetes , is considered the cornerstone of diabetes management. "2, 6, 7, 8, 9, 10, 11" Individuals with chronic diseases such as type 2 diabetes need to participate in health care services to achieve better self-management and better health outcomes. The basis for this is patient activation. Patient activation refers to the knowledge, skills, and confidence of an individual in managing their own health and health care. Patient activation is the driving force of self-management. 12 Literature shows that individuals with high activation levels use more self-management services, exhibit better self-management behaviors such as diet, physical activity, and adherence to treatment plans, and tend to show optimal clinical outcomes such as HbA1c, high-density lipoproteins (HDL), blood pressure, and triglycerides. "2, 8, 12, 13, 14" In addition, more active adult patients believe they are in control of their own health. 17, 18 Highly activation patients show greater self-efficacy, higher quality of life, and lower depression scores. "17, 19, 21, 22, 23, 24, 25" Patients who demonstrate low levels of activation are often apathetic and depressed, have low health-related knowledge, low goal orientation, and poor compliance with any preventive health regimen or treatment, viewing their health as the responsibility of their physicians .
Positive health outcomes obtained with increased patient activation have led researchers to work on activating individuals. Studies examining the factors associated with activation in diabetic individuals are limited. Based on the data obtained from these studies, factors associated with patient activation have been grouped under three headings: demographic, clinical, and psychosocial factors. Demographic factors associated with patient activation have been reported in the literature as age, level of education, gender, race, marital status, and income status. In clinical factors, healthy nutrition, regular exercise, regular health screening, better diabetes control, body mass index, and positive health perception have been found to be associated with patient activation. Psychosocial factors associated with patient activation have been reported as health literacy, patient satisfaction, quality of life, level of hope, negative disease perception, self-efficacy, and depression.
Despite this evidence, there is insufficient literature on the determinants of patient activation in developing countries like ours. The aim of our study is to determine the variables associated with activation in individuals with type 2 diabetes.
- Conditions
- Diabetes Mellitus (DM), Type 2 Diabetes Mellitus (T2DM), Patient Activation, Diabetes Self-management
- Being tested
- Text Message Intervention
- Keywords
- Diabetes Mellitus, Type 2 Diabetes Mellitus, Patient Activation, Patient Activation İnterventions, Improving Patient Activation
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Message InterventionOther
This intervention was prepared by the researcher with the support of artificial intelligence to increase the activation of diabetic individuals in the experimental group. It consists of short messages with the themes of gain, loss and motivation related to diabetes and self-management.
| Study group | Role | What they receive |
|---|---|---|
| Experiment group (Message Sent) | Active comparator | The experimental group consisted of 30 diabetic individuals. As an intervention, it was planned to send short messages containing information about diabetes, created by the researcher, to the diabetic individuals in the experimental group. The short messages were planned to be sent 3 days a week for 8 weeks. Receives: Other: Text Message Intervention |
| Control Group (Message not sent) | No intervention | The control group consists of 30 diabetic individuals. No intervention will be applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Activation Measure
In the first stage of our research, planned as descriptive, the following questions were sought.
In this stage, the Patient Activation Level Measurement Tool (PAM), socio-demographic and disease-related characteristics questionnaire, and the Multidimensional Diabetes Questionnaire were used to measure the activation level of diabetic individuals.
Are the socio-demographic characteristics of diabetic individuals related to the activation level? Are the disease-related characteristics of diabetic individuals related to the activation level? Are the perceived obstacles, perceived severity, perceived self-efficacy, perceived support, perceived outcome expectations of diabetic individuals evaluated with the multidimensional diabetes questionnaire related to the activation level?
Measured: 6 months
Patient Activation Level
In the second experimental phase of the study, it is planned to increase the activation level of diabetic individuals with an intervention. The activation level of diabetic individuals is determined with the Patient Activation Level Measurement Tool (PAM). PAM is a valid, highly reliable, unidimensional, Guttman-type scale. It consists of 13 items. Activation is a four-stage process: 1. Believing in the importance of taking an active role, 2. Knowledge and confidence to take action, 3. Taking action, 4. Maintaining routine even under stress. Activation scores range from 0 to 100. Stage 1: lowest activation: 0-47, Stage 2: 47.1 - 55.1, Stage 3: 55.2 - 67.0, Stage 4: highest activation: 67.1-100 (Hibbard, et al, 2004).
Measured: 6 months
Secondary outcomes (1)
Self-care Behaviors, Metabolic Control Values, Self-Effectiveness Level
The difference between the self-care behaviors of individuals with diabetes participating in the program and those in the control group will be measured. Self-care behavior will be measured with the Diabetes Self-Care Scale. The Diabetes Self-Care Scale is a Likert-type scale and consists of 35 items. The self-care of patients who scored more than 66% of the scale was determined to be at an acceptable level. According to the 4-point Likert-type, the minimum acceptable level of the scale was determined as 92 points. The maximum score of the scale is 140, and as the score increases, the patients' ability to perform self-care activities increases positively. Self-Efficacy level was assessed with the "Self-Efficacy Scale for Type 2 Diabetics". A high score obtained from this Likert-type scale consisting of 20 items indicates a high level of self-efficacy. Metabolic values include fasting-postprandial blood sugar, HbAc, HDL, LDL, total cholesterol levels. Taken from routine measurements.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start2 Jan 2025
- Primary completion30 May 2025 (estimated)
- Study completion25 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus (DM)Studies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a randomized controlled study planned in two stages: descriptive and experimental. In the first descriptive stage, variables related to the activation level of diabetic viruses were determined. Data were collected from 151 diabetic individuals. The second experimental planned stage was conducted on 30 individuals in the experimental group and 30 individuals in the control group, determined by randomization from 151 diabetic individuals whose data were collected in the first stage.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülsüm Yıldız, Dokuz Eylul University
- Investigators
- Dilek Büyükkaya Besen, Associate professor, Study director, Dokuz Eylul University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973954
- Sponsor's protocol ID
- Dokuz EU- HSE-IMN Phd- GY-01
- Status last verified
- Apr 2025
- First submitted
- 19 Apr 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Variables Associated With the Activation Level of Diabetic Individuals and Improvement of Activation Level
- ClinicalTrials.gov ID
- NCT06973954
- Acronym / sponsor ID
- Dokuz EU- HSE-IMN Phd- GY-01
- Conditions
- Diabetes Mellitus (DM), Type 2 Diabetes Mellitus (T2DM), Patient Activation, Diabetes Self-management
- Keywords
- Diabetes Mellitus, Type 2 Diabetes Mellitus, Patient Activation, Patient Activation İnterventions, Improving Patient Activation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 25 Aug 2025 (estimated)
- First posted
- 15 May 2025 (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 was planned to determine the activation levels of diabetic individuals and to improve the activation level. The study, planned as a descriptive and experimental type, is an attempt to increase the activation level of diabetic individuals.
Detailed description
Type 2 diabetes, which is rapidly increasing in prevalence worldwide and poses a global threat, is a complex, chronic condition that requires ongoing medical care with multifactorial risk reduction strategies in addition to glucose management. 1 It causes serious physical and psychological distress to patients and their families, and also imposes a heavy economic burden on society. "2, 3, 4 Therefore, treatment of type 2 diabetes and prevention of its complications are particularly important. Self-management is the key to effective management and control of diabetes. 2, 5 Self-management, which includes activities such as diet, physical activity, self-monitoring of blood sugar, foot care, adherence to medication, and prevention of complications in managing symptoms and lifestyle changes associated with type 2 diabetes , is considered the cornerstone of diabetes management. "2, 6, 7, 8, 9, 10, 11" Individuals with chronic diseases such as type 2 diabetes need to participate in health care services to achieve better self-management and better health outcomes. The basis for this is patient activation. Patient activation refers to the knowledge, skills, and confidence of an individual in managing their own health and health care. Patient activation is the driving force of self-management. 12 Literature shows that individuals with high activation levels use more self-management services, exhibit better self-management behaviors such as diet, physical activity, and adherence to treatment plans, and tend to show optimal clinical outcomes such as HbA1c, high-density lipoproteins (HDL), blood pressure, and triglycerides. "2, 8, 12, 13, 14" In addition, more active adult patients believe they are in control of their own health. 17, 18 Highly activation patients show greater self-efficacy, higher quality of life, and lower depression scores. "17, 19, 21, 22, 23, 24, 25" Patients who demonstrate low levels of activation are often apathetic and depressed, have low health-related knowledge, low goal orientation, and poor compliance with any preventive health regimen or treatment, viewing their health as the responsibility of their physicians .
Positive health outcomes obtained with increased patient activation have led researchers to work on activating individuals. Studies examining the factors associated with activation in diabetic individuals are limited. Based on the data obtained from these studies, factors associated with patient activation have been grouped under three headings: demographic, clinical, and psychosocial factors. Demographic factors associated with patient activation have been reported in the literature as age, level of education, gender, race, marital status, and income status. In clinical factors, healthy nutrition, regular exercise, regular health screening, better diabetes control, body mass index, and positive health perception have been found to be associated with patient activation. Psychosocial factors associated with patient activation have been reported as health literacy, patient satisfaction, quality of life, level of hope, negative disease perception, self-efficacy, and depression.
Despite this evidence, there is insufficient literature on the determinants of patient activation in developing countries like ours. The aim of our study is to determine the variables associated with activation in individuals with type 2 diabetes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a randomized controlled study planned in two stages: descriptive and experimental. In the first descriptive stage, variables related to the activation level of diabetic viruses were determined. Data were collected from 151 diabetic individuals. The second experimental planned stage was conducted on 30 individuals in the experimental group and 30 individuals in the control group, determined by randomization from 151 diabetic individuals whose data were collected in the first stage.
| Arm | Type | Receives |
|---|---|---|
| Experiment group (Message Sent) | Active comparator | Other: Text Message InterventionThe experimental group consisted of 30 diabetic individuals. As an intervention, it was planned to send short messages containing information about diabetes, created by the researcher, to the diabetic individuals in the experimental group. The short messages were planned to be sent 3 days a week for 8 weeks. |
| Control Group (Message not sent) | No intervention | –The control group consists of 30 diabetic individuals. No intervention will be applied to the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Having diabetes for 1 year or more, Able to read and write Turkish, Having no visual, auditory, perceptual or any other physical disability, Having the physical, mental and emotional capacity to participate in self-care activities, Having no language problems, Accepting to participate voluntarily in the study.
Key exclusion criteria (6 listed)
- Individuals with any mental/cognitive problems,
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 |
|---|---|---|
| Text Message InterventionThis intervention was prepared by the researcher with the support of artificial intelligence to increase the activation of diabetic individuals in the experimental group. It consists of short messages with the themes of gain, loss and motivation related to diabetes and self-management. | Other | Experiment group (Message Sent) |
Primary outcome
Patient Activation Measure
Time frame: 6 months
In the first stage of our research, planned as descriptive, the following questions were sought. In this stage, the Patient Activation Level Measurement Tool (PAM), socio-demographic and disease-related characteristics questionnaire, and the Multidimensional Diabetes Questionnaire were used to measure the activation level of diabetic individuals. Are the socio-demographic characteristics of diabetic individuals related to the activation level? Are the disease-related characteristics of diabetic individuals related to the activation level? Are the perceived obstacles, perceived severity, perceived self-efficacy, perceived support, perceived outcome expectations of diabetic individuals evaluated with the multidimensional diabetes questionnaire related to the activation level?
Patient Activation Level
Time frame: 6 months
In the second experimental phase of the study, it is planned to increase the activation level of diabetic individuals with an intervention. The activation level of diabetic individuals is determined with the Patient Activation Level Measurement Tool (PAM). PAM is a valid, highly reliable, unidimensional, Guttman-type scale. It consists of 13 items. Activation is a four-stage process: 1. Believing in the importance of taking an active role, 2. Knowledge and confidence to take action, 3. Taking action, 4. Maintaining routine even under stress. Activation scores range from 0 to 100. Stage 1: lowest activation: 0-47, Stage 2: 47.1 - 55.1, Stage 3: 55.2 - 67.0, Stage 4: highest activation: 67.1-100 (Hibbard, et al, 2004).
1 secondary outcome
Self-care Behaviors, Metabolic Control Values, Self-Effectiveness Level
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: No
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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.
Dilek Büyükkaya Besen, Associate professor study director
Dokuz Eylul University Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Message Intervention in people with Diabetes Mellitus (DM) and Type 2 Diabetes Mellitus (T2DM), run by Dokuz Eylul University at 1 site 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 1 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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 Activation Measure (time frame: 6 months). The study lists 2 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 15 May 2025.