Eficacia comparativa de DSMES familiar y DSMES estándar entre poblaciones diversas
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Arkansas
-
Fayetteville, Arkansas, Estados Unidos, 72703
- University of Arkansas for Medical Sciences Northwest
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Descripción
Criterios de inclusión:
- adultos ≥18 años de edad
- tiene DT2 (HbA1c ≥ 7.0)
- hablar Inglés
- un miembro de la familia dispuesto a participar en el estudio
Criterio de exclusión:
- han recibido DSME formal en los últimos tres años
- tienen una condición que hace que sea poco probable que puedan seguir el protocolo
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Family-DSMES
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.
|
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.
|
|
Comparador activo: Standard-DSMES
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Hemoglobin A1c (HbA1c)
Periodo de tiempo: 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).
|
Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, 18 months post-intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Body Mass Index (BMI)
Periodo de tiempo: Baseline, immediate post-intervention, 6 months post-intervention
|
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).
|
Baseline, immediate post-intervention, 6 months post-intervention
|
|
Systolic Blood Pressure
Periodo de tiempo: Baseline, immediate post-intervention, 6 months post-intervention
|
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.
|
Baseline, immediate post-intervention, 6 months post-intervention
|
|
Diastolic Blood Pressure
Periodo de tiempo: Baseline, immediate post-intervention, 6 months post-intervention
|
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.
|
Baseline, immediate post-intervention, 6 months post-intervention
|
|
Glucose
Periodo de tiempo: Baseline, immediate post-intervention
|
Through finger prick blood collection, point of care tests were used to collect non-fasting blood glucose.
|
Baseline, immediate post-intervention
|
|
Total Cholesterol
Periodo de tiempo: Baseline, immediate post-intervention
|
Through finger prick blood collection, point of care tests were used to collect lipids using a commercial lipid panel kit and Cholestech LDX analyzer.
|
Baseline, immediate post-intervention
|
|
High-Density Lipoproteins (HDL)
Periodo de tiempo: Baseline, immediate post-intervention
|
Through finger prick blood collection, point of care tests were used to collect HDL using a commercial lipid panel kit and Cholestech LDX analyzer.
|
Baseline, immediate post-intervention
|
|
Triglycerides
Periodo de tiempo: Baseline, immediate post-intervention
|
Through finger prick blood collection, point of care tests were used to collect triglycerides using a commercial lipid panel kit and Cholestech LDX analyzer.
|
Baseline, immediate post-intervention
|
|
Low-Density Lipoproteins (LDL)
Periodo de tiempo: Baseline, immediate post-intervention
|
Through finger prick blood collection, point of care tests were used to collect LDL using a commercial lipid panel kit and Cholestech LDX analyzer.
|
Baseline, immediate post-intervention
|
|
Medication Adherence (ARMS-D)
Periodo de tiempo: Baseline, immediate post-intervention
|
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.
|
Baseline, immediate post-intervention
|
|
Diabetes Self-Efficacy (DMSES)
Periodo de tiempo: Baseline, immediate post-intervention
|
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.
|
Baseline, immediate post-intervention
|
|
Diabetes-Related Distress (PAID-5)
Periodo de tiempo: Baseline, immediate post-intervention
|
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.
|
Baseline, immediate post-intervention
|
|
Diabetes-Related Quality of Life (DIDP)
Periodo de tiempo: Baseline, immediate post-intervention
|
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.
|
Baseline, immediate post-intervention
|
|
Diabetes-Related Helpful Family Involvement (FIAD-helpful)
Periodo de tiempo: Baseline, immediate post-intervention
|
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.
|
Baseline, immediate post-intervention
|
|
Diabetes-Related Harmful Family Involvement (FIAD-harmful)
Periodo de tiempo: Baseline, immediate post-intervention
|
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.
|
Baseline, immediate post-intervention
|
|
Diabetes Self-Care Behaviors (SDSCA): Follow Healthful Eating Plan
Periodo de tiempo: Baseline, immediate post-intervention
|
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.
|
Baseline, immediate post-intervention
|
|
Diabetes Self-Care Behaviors (SDSCA): Follow Personal Eating Plan
Periodo de tiempo: Baseline, immediate post-intervention
|
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.
|
Baseline, immediate post-intervention
|
|
Diabetes Self-Care Behaviors (SDSCA): Fruits and Vegetables
Periodo de tiempo: Baseline, immediate post-intervention
|
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.
|
Baseline, immediate post-intervention
|
|
Diabetes Self-Care Behaviors (SDSCA): Fatty Foods
Periodo de tiempo: Baseline, immediate post-intervention
|
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.
|
Baseline, immediate post-intervention
|
|
Diabetes Self-Care Behaviors (SDSCA): Physical Activity
Periodo de tiempo: Baseline, immediate post-intervention
|
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.
|
Baseline, immediate post-intervention
|
|
Diabetes Self-Care Behaviors (SDSCA): Specific Exercise
Periodo de tiempo: Baseline, immediate post-intervention
|
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.
|
Baseline, immediate post-intervention
|
|
Diabetes Self-Care Behaviors (SDSCA): Blood Sugar Test
Periodo de tiempo: Baseline, immediate post-intervention
|
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.
|
Baseline, immediate post-intervention
|
|
Diabetes Self-Care Behaviors (SDSCA): Blood Sugar Test Recommended by Provider
Periodo de tiempo: Baseline, immediate post-intervention
|
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.
|
Baseline, immediate post-intervention
|
|
Diabetes Self-Care Behaviors (SDSCA): Check Feet
Periodo de tiempo: Baseline, immediate post-intervention
|
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.
|
Baseline, immediate post-intervention
|
|
Diabetes Self-Care Behaviors (SDSCA): Inspect Shoes
Periodo de tiempo: Baseline, immediate post-intervention
|
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.
|
Baseline, immediate post-intervention
|
|
Diabetes Self-Care Behaviors (SDSCA): Smoking
Periodo de tiempo: Baseline, immediate post-intervention
|
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.
|
Baseline, immediate post-intervention
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Pearl McElfish, PhD, UAMS
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- Andersen 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 260059
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .