Type2 DiabetesDSMESNCT03464812
Evaluating Outcomes for Ethnically Diverse Patients With Type 2 Diabetes Participating in a Diabetes Education Program
A study testing DSMES in people with Type2 Diabetes, run by Hoag Memorial Hospital Presbyterian at 1 site in United States.
Trial summary
The proposed study has been developed to evaluate patient, physician, and provider (educator) centered barriers to and facilitators for engaging in the Diabetes Self Management Education and Support (DSMES) and developing a patient-centered, physician supported DSMES program that could potentially address barriers… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- DSMES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2017to 5 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of White, Asian, or Hispanic origin (30 in each group) Fluent in English (for the White and Asian group) Fluent in Spanish (for the Hispanic group) Age > 18 years Physician referral for DSME/S Formal diagnosis of type 2 diabetes
Who cannot join
- Current or planned pregnancy. Any medical or other condition that the investigator feels would interfere with study participation.
- Mental incapacity precluding adequate understanding or cooperation. Potential participants who are imprisoned or hospitalized
Trial locations and contacts
1 site in 1 country.
United States1 site
Mary & Dick Allen Diabetes Center, Hoag Hospital
Newport Beach, California, 92663
About this study
Official title: Evaluating Patient Engagement and Other Outcomes for Ethnically Diverse Patients With Type 2 Diabetes Participating in a Structured, Physician Supported, Patient-centered Diabetes Education Program
The proposed study has been developed to evaluate patient, physician, and provider (educator) centered barriers to and facilitators for engaging in the Diabetes Self Management Education and Support (DSMES) and developing a patient-centered, physician supported DSMES program that could potentially address barriers shared by the patients and their healthcare professionals (Phase 1). The feasibility and efficacy of the newly developed program will be evaluated with an ethnically diverse cohort of 90 patients with type 2 diabetes (30 Caucasians, Asians, and Hispanics each) (Phase 2). A variety of outcomes including clinical, behavioral and psycho-social measures will be used to assess program acceptability and effectiveness.
Read the detailed description
Diabetes is a chronic and a progressive metabolic disorder which necessitates active patient involvement to effectively manage nutrition, physical activity, and medication for optimal outcomes. Self-management is a critical aspect of diabetes care and a variety of studies have established the need for people with diabetes to be knowledgeable about their condition and be actively involved in its management to effectively reduce the risk of future health complications and improve other outcomes. Diabetes self-management education and support (DSMES) can help patients effectively engage in and perform their diabetes-related self-care activities. However, only a small number of patients with diabetes participate in DSMES. A few studies in this area have highlighted both physician and patient-related factors that could affect the receipt of DSMES. Patients' involvement in a DSMES program continues to be largely prompted by a physician referral and it has been suggested that improving physician involvement in the DSMES process could enhance overall patient engagement and adherence to such programs.
As part of the proposed mixed methods study, in Phase 1, in-depth surveys (or interviews) will be undertaken with: (a) physicians caring for people with type 2 diabetes, (b) DSMES providers (e.g., certified diabetes educators, diabetes nurses, dietitians), and (b) patients with type 2 diabetes regarding their perception of diabetes education programs, barriers, and facilitators to engagement. Findings from Phase 1 will be shared with the education team at a diabetes center in a community hospital in Orange County, California to inform changes to their currently existing diabetes education curriculum to make it more patient-centered and improve physician engagement and support. As part of Phase 2, the newly developed program will be implemented with a diverse cohort of 90 patients with type 2 diabetes. Patient participation (attendance) in the DSMES process will be documented as a primary marker of patient engagement while their clinical and psycho-social outcomes will serve as secondary indicators. Among other outcomes, physician, educator, and patient satisfaction with the newly developed referral process will also be assessed as a measure of intervention acceptability and success.
- Conditions
- Type2 Diabetes
- Being tested
- DSMES
- Keywords
- Diabetes education, Psychosocial management of diabetes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSMESBehavioural
It is primarily an educational intervention that is focused on assisting patients improve their management and coping with type 2 diabetes.
| Study group | Role | What they receive |
|---|---|---|
| DSMES Group | Other | Patients with type 2 diabetes will undergo a diabetes education program (DSMES) and evaluated for outcomes before and after completing the program. Receives: Behavioral: DSMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program completion
Evaluate the rate of program completion in study participants
Measured: Approximately at 4 months from the start of the study.
Secondary outcomes (6)
Glycemic control
Evaluated using HbA1c (blood test)
Measured: At baseline and repeated after approximately 4 months
Diabetes-specific quality of life
Measure assessing diabetes-specific quality of life
Measured: At baseline and repeated after approximately 4 months
Diabetes-related distress
Measure assessing diabetes-related distress or problem areas in diabetes
Measured: At baseline and repeated after approximately 4 months
Diabetes self-care
Measure assessing diabetes-related self-care
Measured: At baseline and repeated after approximately 4 months
Diabetes-related self efficacy
Measure assessing diabetes-related self-efficacy
Measured: At baseline and repeated after approximately 4 months
Patient and referring provider satisfaction
Measures to assess patient and referring provider related satisfaction with the program.
Measured: Approximately at 4 months from the start of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start4 Aug 2017
- Primary completion5 Aug 2019
- Study completion5 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoag Memorial Hospital Presbyterian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harsimran Harsimran, PhD, Principal investigator, Hoag Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464812
- Sponsor's protocol ID
- RADC2018_1
- Acronym
- DSMES
- Status last verified
- Aug 2019
- First submitted
- 2 Mar 2018
- Last updated
- 14 Jan 2020
- 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 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Patient Engagement and Other Outcomes for Ethnically Diverse Patients With Type 2 Diabetes Participating in a Structured, Physician Supported, Patient-centered Diabetes Education Program
- ClinicalTrials.gov ID
- NCT03464812
- Acronym / sponsor ID
- DSMES / RADC2018_1
- Conditions
- Type2 Diabetes
- Keywords
- Diabetes education, Psychosocial management of diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hoag Memorial Hospital PresbyterianUniversity, hospital or other
- Study start
- 4 Aug 2017 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 5 Aug 2019 (actual)
- First posted
- 14 Mar 2018 (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 proposed study has been developed to evaluate patient, physician, and provider (educator) centered barriers to and facilitators for engaging in the Diabetes Self Management Education and Support (DSMES) and developing a patient-centered, physician supported DSMES program that could potentially address barriers shared by the patients and their healthcare professionals (Phase 1). The feasibility and efficacy of the newly developed program will be evaluated with an ethnically diverse cohort of 90 patients with type 2 diabetes (30 Caucasians, Asians, and Hispanics each) (Phase 2). A variety of outcomes including clinical, behavioral and psycho-social measures will be used to assess program acceptability and effectiveness.
Detailed description
Diabetes is a chronic and a progressive metabolic disorder which necessitates active patient involvement to effectively manage nutrition, physical activity, and medication for optimal outcomes. Self-management is a critical aspect of diabetes care and a variety of studies have established the need for people with diabetes to be knowledgeable about their condition and be actively involved in its management to effectively reduce the risk of future health complications and improve other outcomes. Diabetes self-management education and support (DSMES) can help patients effectively engage in and perform their diabetes-related self-care activities. However, only a small number of patients with diabetes participate in DSMES. A few studies in this area have highlighted both physician and patient-related factors that could affect the receipt of DSMES. Patients' involvement in a DSMES program continues to be largely prompted by a physician referral and it has been suggested that improving physician involvement in the DSMES process could enhance overall patient engagement and adherence to such programs.
As part of the proposed mixed methods study, in Phase 1, in-depth surveys (or interviews) will be undertaken with: (a) physicians caring for people with type 2 diabetes, (b) DSMES providers (e.g., certified diabetes educators, diabetes nurses, dietitians), and (b) patients with type 2 diabetes regarding their perception of diabetes education programs, barriers, and facilitators to engagement. Findings from Phase 1 will be shared with the education team at a diabetes center in a community hospital in Orange County, California to inform changes to their currently existing diabetes education curriculum to make it more patient-centered and improve physician engagement and support. As part of Phase 2, the newly developed program will be implemented with a diverse cohort of 90 patients with type 2 diabetes. Patient participation (attendance) in the DSMES process will be documented as a primary marker of patient engagement while their clinical and psycho-social outcomes will serve as secondary indicators. Among other outcomes, physician, educator, and patient satisfaction with the newly developed referral process will also be assessed as a measure of intervention acceptability and success.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DSMES Group | Other | Behavioral: DSMESPatients with type 2 diabetes will undergo a diabetes education program (DSMES) and evaluated for outcomes before and after completing the program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of White, Asian, or Hispanic origin (30 in each group) Fluent in English (for the White and Asian group) Fluent in Spanish (for the Hispanic group) Age > 18 years Physician referral for DSME/S Formal diagnosis of type 2 diabetes
Key exclusion criteria (2 listed)
- Current or planned pregnancy. Any medical or other condition that the investigator feels would interfere with study participation.
- Mental incapacity precluding adequate understanding or cooperation. Potential participants who are imprisoned or hospitalized
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 |
|---|---|---|
| DSMESIt is primarily an educational intervention that is focused on assisting patients improve their management and coping with type 2 diabetes. | Behavioural | DSMES Group |
Primary outcome
Program completion
Time frame: Approximately at 4 months from the start of the study.
Evaluate the rate of program completion in study participants
6 secondary outcomes
Glycemic control
Time frame: At baseline and repeated after approximately 4 months
Diabetes-specific quality of life
Time frame: At baseline and repeated after approximately 4 months
Diabetes-related distress
Time frame: At baseline and repeated after approximately 4 months
Diabetes self-care
Time frame: At baseline and repeated after approximately 4 months
Diabetes-related self efficacy
Time frame: At baseline and repeated after approximately 4 months
Patient and referring provider satisfaction
Time frame: Approximately at 4 months from the start of the study.
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 14 Jan 2020.
- 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.
Harsimran Harsimran, PhD principal investigator
Hoag 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 DSMES in people with Type2 Diabetes, run by Hoag Memorial Hospital Presbyterian at 1 site in United States.
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 2 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 14 Jan 2020. 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 United States. 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?
Program completion (time frame: Approximately at 4 months from the start of the study.). 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 14 Jan 2020; AzTrials last refreshed its copy on 30 Oct 2026.