Type 2 DiabetesNCT04723628
The Effect of Telephone Consulting on HbA1 and Self-Management
A study testing Intervention group (telephone counseling) in people with Type 2 Diabetes and Self-management, run by Aksaray University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effect of telephone counseling (12 weeks) based on the Information, Motivation, Behavioral Skills (IMB) Model in patients with type 2 diabetes mellitus (T2DM) on self-management and HbA1c. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Self-management
- What is being tested?
- Intervention group (telephone counseling)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 30 Sep 2019
- 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
- Diagnosis with type 2 DM at least six months previously
- Using a mobile phone
- HbA1c greater than 7%
- Living in the city
- Physical and mental health levels adequate for participation in the research
Who cannot join
- Having severe hearing or perceptual deficits that impaired communication
- Patients who did not agree to participate in the study
- Receiving inpatient treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kadriye Sayin Kasar
Aksaray, İlçe Seçiniz, 68100
About this study
Official title: The Effect of Telephone Consultancy Based on the Information, Motivation and Behavioral Skills Model on HbA1c and Self-Management for Individuals With Type 2 Diabetes: A Randomized Controlled Trial
The aim of this study was to investigate the effect of telephone counseling (12 weeks) based on the Information, Motivation, Behavioral Skills (IMB) Model in patients with type 2 diabetes mellitus (T2DM) on self-management and HbA1c.
Read the detailed description
The aim of this study was to investigate the effect of telephone counseling based on the Information, Motivation, Behavioral Skills (IMB) Model in patients with type 2 diabetes mellitus (T2DM) on self-management and HbA1c. This study was conducted with a randomized controlled trial. This study, between January 2019 and September 2019 were conducted in endocrine clinic. A total of 63 patients (31 interventions, 32 controls) diagnosed with T2DM were included. The intervention group received 45-60 minutes of patient training based on the Information, Motivation and Behavioral Skill Model (IMB). A weekly short reminder message and a two-weekly phone call were made and a total of 12 weeks of follow-up was conducted. As a result, there was a statistically significant difference between pre-test HbA1c, weight and systolic blood pressure (p<0.05). Also, after three months of follow-up, self-efficacy, self-management and self-management perceptions were significantly higher in the intervention group (p<0.05).
- Conditions
- Type 2 Diabetes, Self-management
- Being tested
- Intervention group (telephone counseling)
- Keywords
- Type 2 diabetes, Telephone counseling, IMB, Self-management, HbA1c
- 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.
Intervention group (telephone counseling)Behavioural
Then, each patient was given 45-60 minutes of individual instruction. The patient training content was prepared based on the Knowledge, Motivation and Behavioral Skills Model (IMB). A total of 12 weeks of follow-up was performed with a weekly short reminder message and a two-weekly phone call. The research data were collected again at the end of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Then, each patient was given 45-60 minutes of individual instruction. The patient training content was prepared based on the Knowledge, Motivation and Behavioral Skills Model (IMB). A total of 12 weeks of follow-up was performed with a weekly short reminder message and a two-weekly phone call. The research data were collected again at the end of 12 weeks. Receives: Behavioral: Intervention group (telephone counseling) |
| Control group | No intervention | All data forms were then completed, and the HbA1c value was taken from the medical data. No additional procedure was performed to the control group. The research data were collected again at the end of 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control
Glycated hemoglobin (HbA1c) is the most widely used measure of glycemic control. A blood test was used to obtain HbA1c.
Measured: 3 months
Secondary outcomes (3)
Type 2 Diabetes Self-Efficacy Scale
The lowest score obtainable from the scale is 20, and the highest is 100. In the general evaluation of the scale according to the total mean score obtained based on the mean scores of all the subscales, those below the mean score are accepted as low self-efficacy and those above the mean score are accepted as high self-efficacy.
Measured: 3 months
Diabetes Self-Management Questionnaire (DSMQ)
This scale is an individual assessment scale consisting of 16 items to investigate the relationship between diabetes self-management and diabetes control in glycemic control.
Measured: 3 months
Perceived Diabetes Self-Management Scale (PDSMS)
The minimum score which can be obtained from the scale is 8 and the maximum score is 40. A higher total score obtained indicates a better awareness by the person of diabetes management.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Jan 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aksaray University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KADRİYE SAYIN KASAR, Aksaray University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723628
- Sponsor's protocol ID
- AksarayU
- Status last verified
- Jan 2021
- First submitted
- 18 Jan 2021
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sayin Kasar K, Duru Asiret G, Kutmec Yilmaz C, Canlar S. The effect of model-based telephone counseling on HbA1c and self-management for individuals with type 2 diabetes: A randomized controlled trial. Prim Care Diabetes. 2022 Feb;16(1):41-48. doi: 10.1016/j.pcd.2021.09.005. Epub 2021 Sep 11.
PubMed 34518109
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Telephone Consultancy Based on the Information, Motivation and Behavioral Skills Model on HbA1c and Self-Management for Individuals With Type 2 Diabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04723628
- Acronym / sponsor ID
- AksarayU
- Conditions
- Type 2 Diabetes, Self-management
- Keywords
- Type 2 diabetes, Telephone counseling, IMB, Self-management, HbA1c
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Aksaray UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 26 Jan 2021 (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 aim of this study was to investigate the effect of telephone counseling (12 weeks) based on the Information, Motivation, Behavioral Skills (IMB) Model in patients with type 2 diabetes mellitus (T2DM) on self-management and HbA1c.
Detailed description
The aim of this study was to investigate the effect of telephone counseling based on the Information, Motivation, Behavioral Skills (IMB) Model in patients with type 2 diabetes mellitus (T2DM) on self-management and HbA1c. This study was conducted with a randomized controlled trial. This study, between January 2019 and September 2019 were conducted in endocrine clinic. A total of 63 patients (31 interventions, 32 controls) diagnosed with T2DM were included. The intervention group received 45-60 minutes of patient training based on the Information, Motivation and Behavioral Skill Model (IMB). A weekly short reminder message and a two-weekly phone call were made and a total of 12 weeks of follow-up was conducted. As a result, there was a statistically significant difference between pre-test HbA1c, weight and systolic blood pressure (p<0.05). Also, after three months of follow-up, self-efficacy, self-management and self-management perceptions were significantly higher in the intervention group (p<0.05).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Intervention group (telephone counseling)Then, each patient was given 45-60 minutes of individual instruction. The patient training content was prepared based on the Knowledge, Motivation and Behavioral Skills Model (IMB). A total of 12 weeks of follow-up was performed with a weekly short reminder message and a two-weekly phone call. The research data were collected again at the end of 12 weeks. |
| Control group | No intervention | –All data forms were then completed, and the HbA1c value was taken from the medical data. No additional procedure was performed to the control group. The research data were collected again at the end of 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis with type 2 DM at least six months previously
- Using a mobile phone
- HbA1c greater than 7%
- Living in the city
- Physical and mental health levels adequate for participation in the research
Key exclusion criteria (3 listed)
- Having severe hearing or perceptual deficits that impaired communication
- Patients who did not agree to participate in the study
- Receiving inpatient treatment
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 |
|---|---|---|
| Intervention group (telephone counseling)Then, each patient was given 45-60 minutes of individual instruction. The patient training content was prepared based on the Knowledge, Motivation and Behavioral Skills Model (IMB). A total of 12 weeks of follow-up was performed with a weekly short reminder message and a two-weekly phone call. The research data were collected again at the end of 12 weeks. | Behavioural | Experimental group |
Primary outcome
Glycemic Control
Time frame: 3 months
Glycated hemoglobin (HbA1c) is the most widely used measure of glycemic control. A blood test was used to obtain HbA1c.
3 secondary outcomes
Type 2 Diabetes Self-Efficacy Scale
Time frame: 3 months
Diabetes Self-Management Questionnaire (DSMQ)
Time frame: 3 months
Perceived Diabetes Self-Management Scale (PDSMS)
Time frame: 3 months
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 26 Jan 2021.
- Derived from this study: PubMed 34518109Sayin Kasar K, Duru Asiret G, Kutmec Yilmaz C, Canlar S. The effect of model-based telephone counseling on HbA1c and self-management for individuals with type 2 diabetes: A randomized controlled trial. Prim Care Diabetes. 2022 Feb;16(1):41-48. doi: 10.1016/j.pcd.2021.09.005. Epub 2021 Sep 11.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group (telephone counseling) in people with Type 2 Diabetes and Self-management, run by Aksaray 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 5 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 26 Jan 2021. 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?
Glycemic Control (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04723628, which also lists 1 linked publication.
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 26 Jan 2021.