Pre-Existing Type 2 Diabetes MellitusNCT05983120
Self-management and Quality of Life in Individuals With Type 2 Diabetes Mellitus
A study testing Education in people with Pre-Existing Type 2 Diabetes Mellitus, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted in order to study the effect of the training given according to social-cognitive learning theory (SCLT) upon diabetes self-management and quality of life among type 2 diabetes mellitus individuals. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-Existing Type 2 Diabetes Mellitus
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Aug 2021to 3 Jan 2023
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and over
- Being diagnosed with Type 2 diabetes mellitus,
- Being on insulin therapy,
- Being open to verbal communication,
- Being literate
- Not to have an obstacle to continue the implementation phase of the research (for example, pregnancy plan, changing province, etc.)
Show all 17Show fewer
- Not having hearing-vision problems and diabetes-related serious neuropathy (amputation, etc.),
- Patients who agreed to participate in the study.
- Exclusion Criteria:The patient has a perception disorder and psychiatric disorder that prevents communication,
- Being pregnant,
- Individuals with serious complications such as retinopathy and neuropathy at the level of blindness were excluded from the study.
- Research Termination Criteria
- Not performing the specified applications properly during the study,
- Unreachable in follow-ups,
- Those who want to quit working,
- Serious complications related to comorbid diseases and diabetes that occur during the working process,
- The study was terminated with patients who were moved out of the province during the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University
Afyonkarahisar
About this study
Official title: The Effect of Education Provided According to Social Cognitive Learning Theory on Diabetes Self-management and Quality of Life in Individuals With Type 2 Diabetes Mellitus
The study was conducted in order to study the effect of the training given according to social-cognitive learning theory (SCLT) upon diabetes self-management and quality of life among type 2 diabetes mellitus individuals.
Read the detailed description
The study was done as a randomized-controlled experimental study at Internal Diseases Polyclinics of Afyonkarahisar Public Hospital between November 2021 and August 2022. The study was completed with 60 patients -experimental group (30 patients) and control group (30 patients)- who met inclusion criteria. The data were gathered using Information Request Form and Metabolic Variables Form, Diabetes Self-Management Scale (DSMS) for Type 2 Diabetic Patients, Multidimensional Scale of Perceived Social Support (MSPSS), Type 2 Diabetes Mellitus Self-Management Questionnaire (SMQ), WHOQOL-BREF (WHO- Quality of Life Scale- Short form). A theoretical and practical training based on SCLT was provided to the experimental group for the first five weeks -one module for each week- through power point presentations and afterwards, SMS reminders were sent every fifteen days for seven weeks and at the end of the twelfth week the training was completed. The control group received a standard training from diabetes nurse. The data were assessed using statistical methods.
- Conditions
- Pre-Existing Type 2 Diabetes Mellitus
- Being tested
- Education
- Keywords
- Type 2 Diabetes, Social Cognitive Learning, Diabetes Self-management, Quality of Life
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Educate the patients who suffer from Type 2 Diabetes Mellitus
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | In the first five weeks, the experimental group was given training consisting of five modules, accompanied by power point presentations and applied social cognitive learning theory, then SMS reminders were sent every fortnight for seven weeks, and the study was completed at the end of the twelfth week. The control group received standard training from a diabetes nurse. Scale evaluations, metabolic and anthropometric measurements were made at the beginning and end of the study in the experimental and control groups. In addition, the scale evaluation was repeated in the fifth week for the experimental group. Data were evaluated using appropriate statistical methods. Receives: Other: Education |
| Control Group | No intervention | The control group received standard training from a diabetes nurse. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of self-regulation capacity from the principles of SCLT.
There is no specific score range.High scores on the scale indicate good self-management (SMQ), and low scores indicate poor self-management.
In the intervention group, no significant change was observed in SMQ general score averages between PT2 and IT values compared to PT1. Similarly, no significant change was observed in PT2 values compared to PT1 regarding the control group score averages.
Measured: twelve weeks
Determination of self-judgment capacity, one of the principles of SCLT.
DM was assessed with the Self-Efficacy Scale (DSMS). The lowest score that can be obtained from the scale is 20, and the highest score is 100. In the sample, the scale score average is calculated and individuals who are above the average are evaluated as high self-efficacy, and individuals below the average are evaluated as low self-efficacy.
In the study, while the overall median score of DSMS in the intervention group showed a significant decrease in PT2 and IT values compared to PT1, no significant change was observed in the median DSMS scores of the control group.
Measured: twelve weeks
Determining the effect of SCLT-based education on Quality of Life
Evaluated by WHOQOL - BREF (World Health Organization Quality of Life Scale - Short Form). It has four sub-dimensions: physical health such as pain, sleep, energy, psychological health such as positive emotions, self-confidence, body image, social relations such as social support, personal relations and environmental health such as economic status, transportation, safe environment and health conditions. A high score indicates a high quality of life.
In the intervention group, no significant change was observed in the median values of physical health, psychological health, social relations, and environmental health, which are WHOQOL subscales, in PT2 and IT values compared to PT1. Compared to PT1 regarding the median score of the control group's social relations, a minimum significant increase was observed in PT2 values, but no significant change was found in other subscales
Measured: twelve weeks
Secondary outcomes (4)
Determination of blood HbA1c value.
HbA1c (glycosylated hemoglobin). Indicates the average blood glucose value over the last 2 to 3 months. The HbA1c reference range should be 5.7-6.4%. HbA1c level ≥6.5% or ≤5.6 poor glycemic control.
In the intervention group, a significant decrease in the mean values of HbA1c, metabolic variables was observed compared to PT1 (9,53 ± 2,34) and PT2 ( 8,54 ± 1,77).
Measured: twelve weeks
Determination of Fasting Blood Glucose (FBS) value.
It is the glucose value (plasma glucose) measured from a blood sample taken after eight or twelve hours of fasting. The normal reference range is min 80 mg/dl - max 130 mg/dl. FBS level ≥130 mg/dl or ≤80 mg/dl poor glycemic control.
In the intervention group, a significant decrease in the mean values of FBS metabolic variables was observed compared to PT1 (224,77 ± 101,57) and PT2 (168,53 ± 65,27).
Measured: twelve weeks
Determination of blood Postprandial Blood Glucose (PBS) value.
PBS is the plasma glucose value measured two hours after the start of food intake after an eight-hour fast. The reference range is 140-199 mg/dl. TKS ≥200 mg/dl or ≤139 mg/dl a weak glycemic control.
Compared to PT1 (289,13 ± 114,06), the decrease in PBS mean values in PT2 (264,93 ± 91,55) were not significant change was found.
Measured: twelve weeks
Determination of blood fasting lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride) values.
A blood sample taken after eight or twelve hours of fasting is used to determine the fasting lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride) values. Fasting lipid profile reference range is (Total cholesterol 20 - 200 mg/dl, High Density Lipoprotein (HDL) reference range is 35 - 65 mg/dl, Low Density Lipoprotein (LDL) reference range is 60 - 130 mg/dl, Triglyceride reference range is 20 - 203 mg/dl). Values less or higher than the specified values are considered as negative cholesterol levels.
In the intervention group, a significant decrease in the mean values of total cholesterol was observed compared to PT1(192,87 ± 35,87) and PT2 (183,37 ± 36,26) measurements. Compared to PT1, although the decrease in LDL mean values and triglyceride median values in PT2 measurements were not significant, no significant change was found in the HDL value.
Measured: twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start19 Aug 2021
- Primary completion20 Aug 2022
- Study completion3 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Existing Type 2 Diabetes MellitusStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Çelik, Afyonkarahisar Health Sciences University
- Investigators
- Yasemin Celik, Principal investigator, Afyonkarahisar Health Sciences UniversitySibel Karaca Sivrikaya, Study director, Balikesir UniversityAlper Emre Kurt, Study chair, Afyonkarahisar goverment hospitalSezen Yılmaz, Study chair, Afyonkarahisar goverment hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983120
- Sponsor's protocol ID
- Afyonkarahisar HSU
- Status last verified
- Sep 2024
- First submitted
- 7 Jan 2023
- Last updated
- 1 Oct 2024
- 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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Provided According to Social Cognitive Learning Theory on Diabetes Self-management and Quality of Life in Individuals With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05983120
- Acronym / sponsor ID
- Afyonkarahisar HSU
- Conditions
- Pre-Existing Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes, Social Cognitive Learning, Diabetes Self-management, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 9 Aug 2023 (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.
The study was conducted in order to study the effect of the training given according to social-cognitive learning theory (SCLT) upon diabetes self-management and quality of life among type 2 diabetes mellitus individuals.
Detailed description
The study was done as a randomized-controlled experimental study at Internal Diseases Polyclinics of Afyonkarahisar Public Hospital between November 2021 and August 2022. The study was completed with 60 patients -experimental group (30 patients) and control group (30 patients)- who met inclusion criteria. The data were gathered using Information Request Form and Metabolic Variables Form, Diabetes Self-Management Scale (DSMS) for Type 2 Diabetic Patients, Multidimensional Scale of Perceived Social Support (MSPSS), Type 2 Diabetes Mellitus Self-Management Questionnaire (SMQ), WHOQOL-BREF (WHO- Quality of Life Scale- Short form). A theoretical and practical training based on SCLT was provided to the experimental group for the first five weeks -one module for each week- through power point presentations and afterwards, SMS reminders were sent every fifteen days for seven weeks and at the end of the twelfth week the training was completed. The control group received a standard training from diabetes nurse. The data were assessed using statistical methods.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Other: EducationIn the first five weeks, the experimental group was given training consisting of five modules, accompanied by power point presentations and applied social cognitive learning theory, then SMS reminders were sent every fortnight for seven weeks, and the study was completed at the end of the twelfth week. The control group received standard training from a diabetes nurse. Scale evaluations, metabolic and anthropometric measurements were made at the beginning and end of the study in the experimental and control groups. In addition, the scale evaluation was repeated in the fifth week for the experimental group. Data were evaluated using appropriate statistical methods. |
| Control Group | No intervention | –The control group received standard training from a diabetes nurse. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 18 years and over
- Being diagnosed with Type 2 diabetes mellitus,
- Being on insulin therapy,
- Being open to verbal communication,
- Being literate
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| EducationEducate the patients who suffer from Type 2 Diabetes Mellitus | Other | Training group |
Primary outcome
Determination of self-regulation capacity from the principles of SCLT.
Time frame: twelve weeks
There is no specific score range.High scores on the scale indicate good self-management (SMQ), and low scores indicate poor self-management. In the intervention group, no significant change was observed in SMQ general score averages between PT2 and IT values compared to PT1. Similarly, no significant change was observed in PT2 values compared to PT1 regarding the control group score averages.
Determination of self-judgment capacity, one of the principles of SCLT.
Time frame: twelve weeks
DM was assessed with the Self-Efficacy Scale (DSMS). The lowest score that can be obtained from the scale is 20, and the highest score is 100. In the sample, the scale score average is calculated and individuals who are above the average are evaluated as high self-efficacy, and individuals below the average are evaluated as low self-efficacy. In the study, while the overall median score of DSMS in the intervention group showed a significant decrease in PT2 and IT values compared to PT1, no significant change was observed in the median DSMS scores of the control group.
Determining the effect of SCLT-based education on Quality of Life
Time frame: twelve weeks
Evaluated by WHOQOL - BREF (World Health Organization Quality of Life Scale - Short Form). It has four sub-dimensions: physical health such as pain, sleep, energy, psychological health such as positive emotions, self-confidence, body image, social relations such as social support, personal relations and environmental health such as economic status, transportation, safe environment and health conditions. A high score indicates a high quality of life. In the intervention group, no significant change was observed in the median values of physical health, psychological health, social relations, and environmental health, which are WHOQOL subscales, in PT2 and IT values compared to PT1. Compared to PT1 regarding the median score of the control group's social relations, a minimum significant increase was observed in PT2 values, but no significant change was found in other subscales
4 secondary outcomes
Determination of blood HbA1c value.
Time frame: twelve weeks
Determination of Fasting Blood Glucose (FBS) value.
Time frame: twelve weeks
Determination of blood Postprandial Blood Glucose (PBS) value.
Time frame: twelve weeks
Determination of blood fasting lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride) values.
Time frame: twelve weeks
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 1 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Pre-Existing Type 2 Diabetes Mellitus
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Diabetes, Pregnancy
Recruiting
Antenatal Myo-inositol Supplementation in Pre-existing Diabetes
Perinatal and Neonatal Outcomes in Pregnancies With Type 2 Diabetes Mellitus (T2DM)
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.
Yasemin Celik principal investigator
Afyonkarahisar Health Sciences University
Sibel Karaca Sivrikaya study director
Balikesir University
Alper Emre Kurt study chair
Afyonkarahisar goverment hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Pre-Existing Type 2 Diabetes Mellitus, run by Afyonkarahisar Health Sciences 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 17 inclusion and 0 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 1 Oct 2024. 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?
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?
Determination of self-regulation capacity from the principles of SCLT. (time frame: twelve weeks). 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 1 Oct 2024.