Diabetes Mellitus, Type 2NCT04334109
Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations
A study testing Family-DSMES and Standard-DSMES in people with Diabetes Mellitus, Type 2, run by University of Arkansas at 1 site in United States.
Trial summary
The investigators conducted a comparative effectiveness randomized controlled trial comparing a family model diabetes self-management education and support intervention (Family-DSMES) and a standard model DSMES intervention (Standard-DSMES). 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, Type 2
- What is being tested?
- Family-DSMES and Standard-DSMES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to 17 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- adults ≥18 years of age
- have HbA1c ≥ 7.0%
- speak English
- have a family member/support person willing to take part in the study
Who cannot join
- have received formal DSMES in the past three years
- have a condition that makes it unlikely for them to be able to follow the study protocol, such as a terminal illness
- have plans to move out of the area within 18 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences Northwest
Fayetteville, Arkansas, 72703
About this study
The investigators conducted a comparative effectiveness randomized controlled trial comparing a family model diabetes self-management education and support intervention (Family-DSMES) and a standard model DSMES intervention (Standard-DSMES). The trial included 550 persons with type 2 diabetes mellitus (PWD) and 550 of their family members/support persons. PWD were randomly assigned to either the Family-DSMES arm or the Standard-DSMES arm. In the Family-DSMES arm, the family members/support persons of the PWD took part in the educational sessions. In the Standard-DSMES arm, the family members/support persons did not participate in educational sessions or goal setting. Both interventions were delivered in a group setting via telehealth. Baseline, immediate post-intervention (12 weeks) and 6 months post-intervention data were collected from PWD and family members/support persons in both study arms. In both study arms, we obtained a medical records release to abstract the primary outcome at 12 months post-intervention and 18 months post-intervention for PWD. The primary outcome was change in Hemoglobin A1c between baseline and immediate post-intervention among PWD.
Read the detailed description
Approximately 11% of the United States population has type 2 diabetes mellitus, including 12% of Arkansas's population. Diabetes self-management education and support (DSMES) is recommended for people with diabetes (PWD) to support necessary self-management practices and improve health outcomes. Systematic reviews have documented the efficacy of family models of DSMES. To our knowledge, there has been no randomized comparison of the effectiveness of a family model and standard model of DSMES that: 1) evaluates curricula that incorporate elements required for program accreditation/recognition; 2) is implemented among general/diverse populations using curricula that is not culturally adapted; and 3) evaluates outcomes in PWD and family members/support persons. This study addressed important gaps in knowledge by comparing a family-based model of DSMES (Family-DSMES) to standard (individual focused) DSMES (Standard-DSMES). Family-DSMES included PWD and their family members/support persons in educational sessions which explicitly addressed diabetes self-management within a family context, educating both patients and family members/support persons, family goal setting to support the PWD, understanding supportive and non-supportive behaviors, and family behavioral changes.
The overarching research question was "Compared to Standard-DSMES, does Family-DSMES yield improved outcomes among diverse patients with type 2 diabetes mellitus and their family members/support persons?"
The primary outcome was change in hemoglobin A1c (HbA1c) between baseline and post-intervention among PWD. Secondary outcomes for PWD included other biometric outcomes (body mass index, and blood pressure), behavioral outcomes (diabetes self-care behaviors and medication adherence), and psychosocial outcomes (diabetes management self-efficacy, diabetes-related distress, diabetes-related support, family involvement in diabetes management, and diabetes-related quality of life). We also examined the duration of treatment effects by comparing outcomes collected at 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention using HbA1c data extracted from electronic medical records.
PWD were randomly assigned to either the Family-DSMES arm or the Standard-DSMES arm. Family-DSMES was delivered in group sessions via telehealth by a certified diabetes care and education specialist (CDCES) to patients and their family members. The intervention included 10 hours of education delivered over 10 weeks in one-hour sessions. Family members in the Family-DSMES arm took part in educational sessions and data collection. Standard-DSMES was delivered in group sessions via telehealth by a CDCES to patients only. The intervention included 10 hours of education delivered over 10 weeks in one-hour sessions. Family members took part in data collection but did not take part in educational sessions.
We recruited participants through eight primary care clinics across the state of Arkansas. Initial eligibility was determined through medical record abstraction. Patients who were deemed potentially eligible were sent a recruitment letter from their clinic and the Principal Investigator with an explanation of the study, followed up with a phone call from study staff or being approached in the clinic to discuss interest in the study. Potentially eligible and interested PWD were asked to identify a family member/support person to participate in the study with them, who were also contacted by study staff to assess interest and eligibility.
Inclusion criteria for PWD included: 1) adults ≥18 years of age; 2) have HbA1c ≥7.0%; 3) speak English; and 4) have an eligible family member/support person willing to take part in the study. For this study, a family member/support person was defined as "a person living in the same household and/or assisting the patient with household matters." Enrolled family members/support persons were also required to be ≥18 years of age and speak English. Exclusion criteria for PWD included: 1) received formal DSMES in the prior three years; 2) have a condition that makes it unlikely for them to be able to follow the study protocol, such as a terminal illness; and 3) have plans to move out of the area within 18 months.
The enrollment visit took place in a private room at the clinic of the PWD. The enrollment visit was scheduled by study staff at a time where both the person with diabetes and family member/support person could attend. PWD were provided with a study information sheet to review, and to ensure eligibility, a point-of-care measurement of HbA1c was completed. After the HbA1c results confirmed eligibility, study staff met with the PWD and their family member/support person to explain each element of the informed consent. Both the PWD and family member/support person provided written informed consent.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Family-DSMES, Standard-DSMES
- Keywords
- diabetes self-management education and support, type 2 diabetes, comparative effectiveness, randomized controlled trial
- 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.
Family-DSMESBehavioural
Family Diabetes Self-Management Education and Support demonstrates the effectiveness of family-centered models of DSMES that explicitly address diabetes self-management within a family context by educating both patients and family members and focusing on family motivational interviewing, family goal setting, understanding supportive and non-supportive behaviors, and family behavioral changes.
Standard-DSMESBehavioural
Diabetes Self-Management Education and Support demonstrates the effectiveness of individual model DSMES that explicitly address diabetes self-management within an individual context by educating individual patients on individual motivational interviewing, individual goal setting, and individual behavioral changes.
| Study group | Role | What they receive |
|---|---|---|
| Family-DSMES | Experimental | The Family-DSMES intervention uses family motivational interviewing techniques and family goal setting, and focuses on understanding supportive and non-supportive family behaviors and creating family level behavioral change. Family-DSMES is delivered in group sessions via telehealth by a certified diabetes care and education specialist (CDCES) to patients and their family members. The intervention includes 10 hours of education delivered over 10 weeks in one-hour sessions. Family members in the Family-DSMES arm take part in educational sessions and data collection. Receives: Behavioral: Family-DSMES |
| Standard-DSMES | Active comparator | The Standard-DSMES intervention uses individual motivational interviewing techniques and individual goal setting, and focuses on creating individual level behavioral change. Standard-DSMES is delivered in group sessions via telehealth by a certified diabetes care and education specialist (CDCES) to patients only. The intervention includes 10 hours of education delivered over 10 weeks in one-hour sessions. Family members take part in data collection but do not take part in educational sessions. Receives: Behavioral: Standard-DSMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c (HbA1c)
A Siemens DCA Vantage analyzer was utilized to collect HbA1c from participants via finger stick blood collection (except for 12 months post-intervention and 18 months post-intervention, which was collected through medical record abstractions).
Measured: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, 18 months post-intervention
Secondary outcomes (25)
Body Mass Index (BMI)
Participant height (without shoes) was collected using a stadiometer and participant weight (without shoes) was collected using a calibrated digital scale. Height and weight were used to compute a continuous measure of BMI (kilograms per square meter).
Measured: Baseline, immediate post-intervention, 6 months post-intervention
Systolic Blood Pressure
Blood pressure was measured with a digital blood pressure device with the participant seated and arm elevated to place the cuff approximately at heart height. Two blood pressure measurements were taken, waiting at least one minute between readings. The two measurements were averaged and recorded.
Measured: Baseline, immediate post-intervention, 6 months post-intervention
Diastolic Blood Pressure
Blood pressure was measured with a digital blood pressure device with the participant seated and arm elevated to place the cuff approximately at heart height. Two blood pressure measurements were taken, waiting at least one minute between readings. The two measurements were averaged and recorded.
Measured: Baseline, immediate post-intervention, 6 months post-intervention
Glucose
Through finger prick blood collection, point of care tests were used to collect non-fasting blood glucose.
Measured: Baseline, immediate post-intervention
Total Cholesterol
Through finger prick blood collection, point of care tests were used to collect lipids using a commercial lipid panel kit and Cholestech LDX analyzer.
Measured: Baseline, immediate post-intervention
High-Density Lipoproteins (HDL)
Through finger prick blood collection, point of care tests were used to collect HDL using a commercial lipid panel kit and Cholestech LDX analyzer.
Measured: Baseline, immediate post-intervention
Triglycerides
Through finger prick blood collection, point of care tests were used to collect triglycerides using a commercial lipid panel kit and Cholestech LDX analyzer.
Measured: Baseline, immediate post-intervention
Low-Density Lipoproteins (LDL)
Through finger prick blood collection, point of care tests were used to collect LDL using a commercial lipid panel kit and Cholestech LDX analyzer.
Measured: Baseline, immediate post-intervention
Medication Adherence (ARMS-D)
The Adherence to Refills and Medications Scale for Diabetes Medicines (ARMS-D) was used to measure patient's adherence to their medications (if prescribed). The ARMS-D uses 12 items to assess self-reported adherence to diabetes medications. Item responses range from 1 (none of the time) to 4 (all of the time) and are summed to produce an overall adherence score with a possible range of 12-48, with higher scores representing more problems with medication adherence.
Measured: Baseline, immediate post-intervention
Diabetes Self-Efficacy (DMSES)
The Diabetes Management Self-Efficacy Scale (DMSES) was used to measure patient's confidence in managing their diabetes. The DMSES assesses self-reported confidence in managing multiple aspects of their diabetes. The item reponses range from 1 (not at all confident) to 10 (totally confident) and are averaged to generate composite scores, with higher scores indicating higher levels of self-efficacy.
Measured: Baseline, immediate post-intervention
Diabetes-Related Distress (PAID-5)
The Problem Areas in Diabetes scale (PAID-5) was used to measure diabetes-related distress. The PAID-5 consists of 5 items to assess self-reported diabetes-related emotional distress, including feeling scared or depressed. Item responses range from 0 (not a problem) to 4 (serious problem) and are summed to produce an overall composite score, with a total score of 8 or higher indicating possible diabetes-related emotional distress.
Measured: Baseline, immediate post-intervention
Diabetes-Related Quality of Life (DIDP)
The Diabetes Attitudes Wishes and Needs (DAWN2) study Impact of Diabetes Profile (DIDP) was used to measure the perceived impact of diabetes on patients' quality of life. The DIDP consists of 6 items to assess self-reported impacts on quality of life, including physical health, financial situation, and relationships with others. Item responses range from 1 (very negative impact) to 7 (very positive impact) and are reverse scored and averaged to generate composite scores, with lower scores indicating greater positive impact and higher scores indicating greater negative impact.
Measured: Baseline, immediate post-intervention
Diabetes-Related Helpful Family Involvement (FIAD-helpful)
The Family and Friend Involvement in Adults' Diabetes (FIAD) scale was used to measure participants' perception of helpful involvement of their friends and family in managing their diabetes. Item responses range from 1 (never in the past month) to 5 (twice or more each week) and are averaged to generate composite scores for helpful family involvement, with higher scores indicating more frequent helpful involvement.
Measured: Baseline, immediate post-intervention
Diabetes-Related Harmful Family Involvement (FIAD-harmful)
The Family and Friend Involvement in Adults' Diabetes (FIAD) scale was used to measure participants' perception of harmful involvement of their friends and family in managing their diabetes. Item responses range from 1 (never in the past month) to 5 (twice or more each week) and are averaged to generate composite scores for harmful family involvement, with higher scores indicating more frequent harmful involvement.
Measured: Baseline, immediate post-intervention
Diabetes Self-Care Behaviors (SDSCA): Follow Healthful Eating Plan
Items from the Summary of Diabetes Self-Care Activities (SDSCA) were used to assess engagement in diabetes self-care behaviors over the past week. This item assessed how often participants followed a healthful eating plan over the past week. Item responses range from 0 days to 7 days, with higher scores indicating more frequent behavior (more days in the past week). Items in the SDSCA scale were analyzed separately.
Measured: Baseline, immediate post-intervention
Diabetes Self-Care Behaviors (SDSCA): Follow Personal Eating Plan
Items from the Summary of Diabetes Self-Care Activities (SDSCA) were used to assess engagement in diabetes self-care behaviors over the past week. This item assessed how often participants followed their personally tailored eating plan over the past week. Item responses range from 0 days to 7 days, with higher scores indicating more frequent behavior (more days in the past week). Items in the SDSCA scale were analyzed separately.
Measured: Baseline, immediate post-intervention
Diabetes Self-Care Behaviors (SDSCA): Fruits and Vegetables
Items from the Summary of Diabetes Self-Care Activities (SDSCA) were used to assess engagement in diabetes self-care behaviors over the past week. This item assessed how often participants ate five or more servings of fruits and vegetables over the past week. Item responses range from 0 days to 7 days, with higher scores indicating more frequent behavior (more days in the past week). Items in the SDSCA scale were analyzed separately.
Measured: Baseline, immediate post-intervention
Diabetes Self-Care Behaviors (SDSCA): Fatty Foods
Items from the Summary of Diabetes Self-Care Activities (SDSCA) were used to assess engagement in diabetes self-care behaviors over the past week. This item assessed how often participants ate high fat foods such as red meat or full-fat dairy over the past week. Item responses range from 0 days to 7 days, with higher scores indicating more frequent behavior (more days in the past week). Items in the SDSCA scale were analyzed separately.
Measured: Baseline, immediate post-intervention
Diabetes Self-Care Behaviors (SDSCA): Physical Activity
Items from the Summary of Diabetes Self-Care Activities (SDSCA) were used to assess engagement in diabetes self-care behaviors over the past week. This item assessed how often participants participated in at least 30 minutes of continuous physical activity over the past week. Item responses range from 0 days to 7 days, with higher scores indicating more frequent behavior (more days in the past week). Items in the SDSCA scale were analyzed separately.
Measured: Baseline, immediate post-intervention
Diabetes Self-Care Behaviors (SDSCA): Specific Exercise
Items from the Summary of Diabetes Self-Care Activities (SDSCA) were used to assess engagement in diabetes self-care behaviors over the past week. This item assessed how often participants participated in a specific exercise session (such as swimming, walking, biking) over the past week. Item responses range from 0 days to 7 days, with higher scores indicating more frequent behavior (more days in the past week). Items in the SDSCA scale were analyzed separately.
Measured: Baseline, immediate post-intervention
Diabetes Self-Care Behaviors (SDSCA): Blood Sugar Test
Items from the Summary of Diabetes Self-Care Activities (SDSCA) were used to assess engagement in diabetes self-care behaviors over the past week. This item assessed how often participants tested their blood sugar over the past week. Item responses range from 0 days to 7 days, with higher scores indicating more frequent behavior (more days in the past week). Items in the SDSCA scale were analyzed separately.
Measured: Baseline, immediate post-intervention
Diabetes Self-Care Behaviors (SDSCA): Blood Sugar Test Recommended by Provider
Items from the Summary of Diabetes Self-Care Activities (SDSCA) were used to assess engagement in diabetes self-care behaviors over the past week. This item assessed how often participants tested their blood sugar the number of times recommended by their healthcare provider over the past week. Item responses range from 0 days to 7 days, with higher scores indicating more frequent behavior (more days in the past week). Items in the SDSCA scale were analyzed separately.
Measured: Baseline, immediate post-intervention
Diabetes Self-Care Behaviors (SDSCA): Check Feet
Items from the Summary of Diabetes Self-Care Activities (SDSCA) were used to assess engagement in diabetes self-care behaviors over the past week. This item assessed how often participants checked their feet over the past week. Item responses range from 0 days to 7 days, with higher scores indicating more frequent behavior (more days in the past week). Items in the SDSCA scale were analyzed separately.
Measured: Baseline, immediate post-intervention
Diabetes Self-Care Behaviors (SDSCA): Inspect Shoes
Items from the Summary of Diabetes Self-Care Activities (SDSCA) were used to assess engagement in diabetes self-care behaviors over the past week. This item assessed how often participants inspected the inside of their shoes over the past week. Item responses range from 0 days to 7 days, with higher scores indicating more frequent behavior (more days in the past week). Items in the SDSCA scale were analyzed separately.
Measured: Baseline, immediate post-intervention
Diabetes Self-Care Behaviors (SDSCA): Smoking
Items from the Summary of Diabetes Self-Care Activities (SDSCA) were used to assess engagement in diabetes self-care behaviors over the past week. This item assessed whether participants had smoked in the past week (yes=1; no=0). Items in the SDSCA scale were analyzed separately. The mean estimates of this outcome are presented on the odds scale from logistic generalized estimating equation models.
Measured: Baseline, immediate post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start4 Jan 2021
- Primary completion17 May 2023
- Study completion17 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Pearl McElfish, PhD, Principal investigator, UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334109
- Sponsor's protocol ID
- 260059
- Status last verified
- Jun 2026
- First submitted
- 26 Mar 2020
- Last updated
- 22 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mayberry LS, Felix HC, Hudson J, Curran GM, Long CR, Selig JP, Carleton A, Baig A, Warshaw H, Peyrot M, McElfish PA. Effectiveness-implementation trial comparing a family model of diabetes self-management education and support with a standard model. Contemp Clin Trials. 2022 Oct;121:106921. doi: 10.1016/j.cct.2022.106921. Epub 2022 Sep 9.
PubMed 36096282Andersen JA, McElfish PA, Selig JP, Li J, Rowland B, Hudson J, Kraleti S, Henske J, Mayberry LS. Comparative effectiveness of telehealth-delivered family and standard models of diabetes self-management education and support for persons with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2026 Feb;232:113063. doi: 10.1016/j.diabres.2025.113063. Epub 2025 Dec 20.
PubMed 41429275
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations
- ClinicalTrials.gov ID
- NCT04334109
- Acronym / sponsor ID
- 260059
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes self-management education and support, type 2 diabetes, comparative effectiveness, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 17 May 2023 (actual)
- Study completion
- 17 Sep 2024 (actual)
- First posted
- 6 Apr 2020 (actual)
- Results
- Posted 22 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators conducted a comparative effectiveness randomized controlled trial comparing a family model diabetes self-management education and support intervention (Family-DSMES) and a standard model DSMES intervention (Standard-DSMES). The trial included 550 persons with type 2 diabetes mellitus (PWD) and 550 of their family members/support persons. PWD were randomly assigned to either the Family-DSMES arm or the Standard-DSMES arm. In the Family-DSMES arm, the family members/support persons of the PWD took part in the educational sessions. In the Standard-DSMES arm, the family members/support persons did not participate in educational sessions or goal setting. Both interventions were delivered in a group setting via telehealth. Baseline, immediate post-intervention (12 weeks) and 6 months post-intervention data were collected from PWD and family members/support persons in both study arms. In both study arms, we obtained a medical records release to abstract the primary outcome at 12 months post-intervention and 18 months post-intervention for PWD. The primary outcome was change in Hemoglobin A1c between baseline and immediate post-intervention among PWD.
Detailed description
Approximately 11% of the United States population has type 2 diabetes mellitus, including 12% of Arkansas's population. Diabetes self-management education and support (DSMES) is recommended for people with diabetes (PWD) to support necessary self-management practices and improve health outcomes. Systematic reviews have documented the efficacy of family models of DSMES. To our knowledge, there has been no randomized comparison of the effectiveness of a family model and standard model of DSMES that: 1) evaluates curricula that incorporate elements required for program accreditation/recognition; 2) is implemented among general/diverse populations using curricula that is not culturally adapted; and 3) evaluates outcomes in PWD and family members/support persons. This study addressed important gaps in knowledge by comparing a family-based model of DSMES (Family-DSMES) to standard (individual focused) DSMES (Standard-DSMES). Family-DSMES included PWD and their family members/support persons in educational sessions which explicitly addressed diabetes self-management within a family context, educating both patients and family members/support persons, family goal setting to support the PWD, understanding supportive and non-supportive behaviors, and family behavioral changes.
The overarching research question was "Compared to Standard-DSMES, does Family-DSMES yield improved outcomes among diverse patients with type 2 diabetes mellitus and their family members/support persons?"
The primary outcome was change in hemoglobin A1c (HbA1c) between baseline and post-intervention among PWD. Secondary outcomes for PWD included other biometric outcomes (body mass index, and blood pressure), behavioral outcomes (diabetes self-care behaviors and medication adherence), and psychosocial outcomes (diabetes management self-efficacy, diabetes-related distress, diabetes-related support, family involvement in diabetes management, and diabetes-related quality of life). We also examined the duration of treatment effects by comparing outcomes collected at 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention using HbA1c data extracted from electronic medical records.
PWD were randomly assigned to either the Family-DSMES arm or the Standard-DSMES arm. Family-DSMES was delivered in group sessions via telehealth by a certified diabetes care and education specialist (CDCES) to patients and their family members. The intervention included 10 hours of education delivered over 10 weeks in one-hour sessions. Family members in the Family-DSMES arm took part in educational sessions and data collection. Standard-DSMES was delivered in group sessions via telehealth by a CDCES to patients only. The intervention included 10 hours of education delivered over 10 weeks in one-hour sessions. Family members took part in data collection but did not take part in educational sessions.
We recruited participants through eight primary care clinics across the state of Arkansas. Initial eligibility was determined through medical record abstraction. Patients who were deemed potentially eligible were sent a recruitment letter from their clinic and the Principal Investigator with an explanation of the study, followed up with a phone call from study staff or being approached in the clinic to discuss interest in the study. Potentially eligible and interested PWD were asked to identify a family member/support person to participate in the study with them, who were also contacted by study staff to assess interest and eligibility.
Inclusion criteria for PWD included: 1) adults ≥18 years of age; 2) have HbA1c ≥7.0%; 3) speak English; and 4) have an eligible family member/support person willing to take part in the study. For this study, a family member/support person was defined as "a person living in the same household and/or assisting the patient with household matters." Enrolled family members/support persons were also required to be ≥18 years of age and speak English. Exclusion criteria for PWD included: 1) received formal DSMES in the prior three years; 2) have a condition that makes it unlikely for them to be able to follow the study protocol, such as a terminal illness; and 3) have plans to move out of the area within 18 months.
The enrollment visit took place in a private room at the clinic of the PWD. The enrollment visit was scheduled by study staff at a time where both the person with diabetes and family member/support person could attend. PWD were provided with a study information sheet to review, and to ensure eligibility, a point-of-care measurement of HbA1c was completed. After the HbA1c results confirmed eligibility, study staff met with the PWD and their family member/support person to explain each element of the informed consent. Both the PWD and family member/support person provided written informed consent.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family-DSMES | Experimental | Behavioral: Family-DSMESThe Family-DSMES intervention uses family motivational interviewing techniques and family goal setting, and focuses on understanding supportive and non-supportive family behaviors and creating family level behavioral change. Family-DSMES is delivered in group sessions via telehealth by a certified diabetes care and education specialist (CDCES) to patients and their family members. The intervention includes 10 hours of education delivered over 10 weeks in one-hour sessions. Family members in the Family-DSMES arm take part in educational sessions and data collection. |
| Standard-DSMES | Active comparator | Behavioral: Standard-DSMESThe Standard-DSMES intervention uses individual motivational interviewing techniques and individual goal setting, and focuses on creating individual level behavioral change. Standard-DSMES is delivered in group sessions via telehealth by a certified diabetes care and education specialist (CDCES) to patients only. The intervention includes 10 hours of education delivered over 10 weeks in one-hour sessions. Family members take part in data collection but do not take part in educational sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults ≥18 years of age
- have HbA1c ≥ 7.0%
- speak English
- have a family member/support person willing to take part in the study
Key exclusion criteria (3 listed)
- have received formal DSMES in the past three years
- have a condition that makes it unlikely for them to be able to follow the study protocol, such as a terminal illness
- have plans to move out of the area within 18 months
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 |
|---|---|---|
| Family-DSMESFamily Diabetes Self-Management Education and Support demonstrates the effectiveness of family-centered models of DSMES that explicitly address diabetes self-management within a family context by educating both patients and family members and focusing on family motivational interviewing, family goal setting, understanding supportive and non-supportive behaviors, and family behavioral changes. | Behavioural | Family-DSMES |
| Standard-DSMESDiabetes Self-Management Education and Support demonstrates the effectiveness of individual model DSMES that explicitly address diabetes self-management within an individual context by educating individual patients on individual motivational interviewing, individual goal setting, and individual behavioral changes. | Behavioural | Standard-DSMES |
Primary outcome
Hemoglobin A1c (HbA1c)
Time frame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, 18 months post-intervention
A Siemens DCA Vantage analyzer was utilized to collect HbA1c from participants via finger stick blood collection (except for 12 months post-intervention and 18 months post-intervention, which was collected through medical record abstractions).
25 secondary outcomes
Body Mass Index (BMI)
Time frame: Baseline, immediate post-intervention, 6 months post-intervention
Systolic Blood Pressure
Time frame: Baseline, immediate post-intervention, 6 months post-intervention
Diastolic Blood Pressure
Time frame: Baseline, immediate post-intervention, 6 months post-intervention
Glucose
Time frame: Baseline, immediate post-intervention
Total Cholesterol
Time frame: Baseline, immediate post-intervention
High-Density Lipoproteins (HDL)
Time frame: Baseline, immediate post-intervention
Triglycerides
Time frame: Baseline, immediate post-intervention
Low-Density Lipoproteins (LDL)
Time frame: Baseline, immediate post-intervention
Medication Adherence (ARMS-D)
Time frame: Baseline, immediate post-intervention
Diabetes Self-Efficacy (DMSES)
Time frame: Baseline, immediate post-intervention
Diabetes-Related Distress (PAID-5)
Time frame: Baseline, immediate post-intervention
Diabetes-Related Quality of Life (DIDP)
Time frame: Baseline, immediate post-intervention
Diabetes-Related Helpful Family Involvement (FIAD-helpful)
Time frame: Baseline, immediate post-intervention
Diabetes-Related Harmful Family Involvement (FIAD-harmful)
Time frame: Baseline, immediate post-intervention
Diabetes Self-Care Behaviors (SDSCA): Follow Healthful Eating Plan
Time frame: Baseline, immediate post-intervention
Diabetes Self-Care Behaviors (SDSCA): Follow Personal Eating Plan
Time frame: Baseline, immediate post-intervention
Diabetes Self-Care Behaviors (SDSCA): Fruits and Vegetables
Time frame: Baseline, immediate post-intervention
Diabetes Self-Care Behaviors (SDSCA): Fatty Foods
Time frame: Baseline, immediate post-intervention
Diabetes Self-Care Behaviors (SDSCA): Physical Activity
Time frame: Baseline, immediate post-intervention
Diabetes Self-Care Behaviors (SDSCA): Specific Exercise
Time frame: Baseline, immediate post-intervention
Diabetes Self-Care Behaviors (SDSCA): Blood Sugar Test
Time frame: Baseline, immediate post-intervention
Diabetes Self-Care Behaviors (SDSCA): Blood Sugar Test Recommended by Provider
Time frame: Baseline, immediate post-intervention
Diabetes Self-Care Behaviors (SDSCA): Check Feet
Time frame: Baseline, immediate post-intervention
Diabetes Self-Care Behaviors (SDSCA): Inspect Shoes
Time frame: Baseline, immediate post-intervention
Diabetes Self-Care Behaviors (SDSCA): Smoking
Time frame: Baseline, immediate post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36096282Mayberry LS, Felix HC, Hudson J, Curran GM, Long CR, Selig JP, Carleton A, Baig A, Warshaw H, Peyrot M, McElfish PA. Effectiveness-implementation trial comparing a family model of diabetes self-management education and support with a standard model. Contemp Clin Trials. 2022 Oct;121:106921. doi: 10.1016/j.cct.2022.106921. Epub 2022 Sep 9.
- Results publication: PubMed 41429275Andersen JA, McElfish PA, Selig JP, Li J, Rowland B, Hudson J, Kraleti S, Henske J, Mayberry LS. Comparative effectiveness of telehealth-delivered family and standard models of diabetes self-management education and support for persons with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2026 Feb;232:113063. doi: 10.1016/j.diabres.2025.113063. Epub 2025 Dec 20.
- 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.
Pearl McElfish, PhD principal investigator
UAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-DSMES and Standard-DSMES in people with Diabetes Mellitus, Type 2, run by University of Arkansas 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 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 22 Jun 2026. 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?
Yes. Results are posted in the registry (first posted 22 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hemoglobin A1c (HbA1c) (time frame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, 18 months post-intervention). 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 NCT04334109, which also lists 2 linked publications.
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 22 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.