Improving Health Communication During the Transition From Pediatric to Adult Diabetes Care
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 17 - 23 |
| Updated: | 11/18/2018 |
| Start Date: | November 6, 2018 |
| End Date: | December 2022 |
Adolescents and young adults (AYAs; ages 17-23) with type 1 diabetes are at high risk for
negative health outcomes, including poor glycemic control and disengagement from the health
care system. The deterioration of glycemic control occurs in parallel with the assumption of
independent self-care skills and preparation for adult diabetes care. Effective communication
between AYAs and health care providers may be a critical contributor to diabetes self-care
skills during the transition to adult diabetes care and related glycemic control. This
research will attempt to better prepare adolescents and young adults for adult diabetes care
by delivering innovative intervention content focused on both health communication skills and
transition readiness skills. The investigators aim to leverage innovative technologies to
improve developmentally-appropriate communication skills related to planning for clinic
visits, disclosing and discussing diabetes-related concerns, and optimizing glucose data
review in preparation for adult diabetes care. Adolescents and young adults with type 1
diabetes (ages 17-23) who are planning to transition to adult diabetes care within the next
6-8 months will be enrolled in the study and randomized to either the intervention group or a
standard care control group. Medical, communication, and psychosocial data (including A1c,
glucose monitoring frequency, communication quality, health care engagement, depressive
symptoms) will be collected from adolescent and young adult participants and health care
providers at baseline and two follow-up time points, approximately 4 months post-baseline and
approximately 8-12 months post-baseline after the transfer to adult diabetes care. This
intervention has the potential to improve diabetes self-care skills, including engagement
with health care providers, and glycemic control in AYAs with type 1 diabetes during the
vulnerable period of transfer to adult diabetes care. The results of this work will inform
best practices for transition to adult diabetes care and can be translated into clinical
care.
negative health outcomes, including poor glycemic control and disengagement from the health
care system. The deterioration of glycemic control occurs in parallel with the assumption of
independent self-care skills and preparation for adult diabetes care. Effective communication
between AYAs and health care providers may be a critical contributor to diabetes self-care
skills during the transition to adult diabetes care and related glycemic control. This
research will attempt to better prepare adolescents and young adults for adult diabetes care
by delivering innovative intervention content focused on both health communication skills and
transition readiness skills. The investigators aim to leverage innovative technologies to
improve developmentally-appropriate communication skills related to planning for clinic
visits, disclosing and discussing diabetes-related concerns, and optimizing glucose data
review in preparation for adult diabetes care. Adolescents and young adults with type 1
diabetes (ages 17-23) who are planning to transition to adult diabetes care within the next
6-8 months will be enrolled in the study and randomized to either the intervention group or a
standard care control group. Medical, communication, and psychosocial data (including A1c,
glucose monitoring frequency, communication quality, health care engagement, depressive
symptoms) will be collected from adolescent and young adult participants and health care
providers at baseline and two follow-up time points, approximately 4 months post-baseline and
approximately 8-12 months post-baseline after the transfer to adult diabetes care. This
intervention has the potential to improve diabetes self-care skills, including engagement
with health care providers, and glycemic control in AYAs with type 1 diabetes during the
vulnerable period of transfer to adult diabetes care. The results of this work will inform
best practices for transition to adult diabetes care and can be translated into clinical
care.
Research Design and Methods Overview of Study Design & Procedure. The aim of this randomized
controlled trial (RCT) is to determine the efficacy of a behavioral intervention targeting
health communication skills and diabetes self-management skills in preparation for the
transfer to adult diabetes care, compared to usual care. The intervention, Plan, Reflect, and
Engage with Providers for Diabetes Care (PREP-DC), consists of three intervention sessions
with a study interventionist, paired text messages, and access to glucose management
software. It is expected that adolescents and young adults allocated to the intervention
condition (PREP-DC) will evidence: 1) better glycemic control (lower A1c); 2) shorter gap in
time between the last visit in pediatric diabetes care and the first visit in adult diabetes
care; 3) better diabetes management (better adherence to the diabetes regimen); 4) fewer
reported complications (e.g. hospitalizations and emergency department visits). A total of
100 adolescent and young adult participants (ages 17-23) will be randomly allocated in a 1:1
ratio to either the PREP-DC intervention condition (n=50) or usual care (n=50; standard care
comparison condition): all participants receive standard resources for transition to adult
diabetes care as part of usual care in both conditions.
Participants include 100 adolescents and young adults (ages 17-23) diagnosed with T1D for at
least one year (anticipated 50% female) seen for diabetes care at Children's National Medical
Center (CNMC) in Washington, DC. Eligible participants will self-identify as planning to
transfer to adult diabetes care within the upcoming 6-8 months. Participants in the PREP-DC
intervention will complete three intervention sessions with study team members over a 3 month
period (approximately 1 intervention session per month). Two sessions will be with a trained
study interventionist focusing on communication with health care providers and preparation
for medical visits and adult diabetes care. One session will be with a certified diabetes
education focusing on problem-solving using glucose data and glucose data review. PREP-DC
intervention participants will also receive text messages (3-4 messages/week) for the 3 month
intervention period supporting intervention content. Participants also will be given
information about accessing glucose management software specific to their diabetes devices
and related study resources (e.g. study website). Participants are evaluated at baseline
(pre-randomization to intervention or standard care comparison group) and follow-up
(approximately 4 months post-baseline and approximately 8-12 months post-baseline after the
transition to adult diabetes care).
controlled trial (RCT) is to determine the efficacy of a behavioral intervention targeting
health communication skills and diabetes self-management skills in preparation for the
transfer to adult diabetes care, compared to usual care. The intervention, Plan, Reflect, and
Engage with Providers for Diabetes Care (PREP-DC), consists of three intervention sessions
with a study interventionist, paired text messages, and access to glucose management
software. It is expected that adolescents and young adults allocated to the intervention
condition (PREP-DC) will evidence: 1) better glycemic control (lower A1c); 2) shorter gap in
time between the last visit in pediatric diabetes care and the first visit in adult diabetes
care; 3) better diabetes management (better adherence to the diabetes regimen); 4) fewer
reported complications (e.g. hospitalizations and emergency department visits). A total of
100 adolescent and young adult participants (ages 17-23) will be randomly allocated in a 1:1
ratio to either the PREP-DC intervention condition (n=50) or usual care (n=50; standard care
comparison condition): all participants receive standard resources for transition to adult
diabetes care as part of usual care in both conditions.
Participants include 100 adolescents and young adults (ages 17-23) diagnosed with T1D for at
least one year (anticipated 50% female) seen for diabetes care at Children's National Medical
Center (CNMC) in Washington, DC. Eligible participants will self-identify as planning to
transfer to adult diabetes care within the upcoming 6-8 months. Participants in the PREP-DC
intervention will complete three intervention sessions with study team members over a 3 month
period (approximately 1 intervention session per month). Two sessions will be with a trained
study interventionist focusing on communication with health care providers and preparation
for medical visits and adult diabetes care. One session will be with a certified diabetes
education focusing on problem-solving using glucose data and glucose data review. PREP-DC
intervention participants will also receive text messages (3-4 messages/week) for the 3 month
intervention period supporting intervention content. Participants also will be given
information about accessing glucose management software specific to their diabetes devices
and related study resources (e.g. study website). Participants are evaluated at baseline
(pre-randomization to intervention or standard care comparison group) and follow-up
(approximately 4 months post-baseline and approximately 8-12 months post-baseline after the
transition to adult diabetes care).
Inclusion Criteria:
- Diagnosed with type1 diabetes for ≥ 1 year
- Able to adequately understand, speak, and read English to benefit from participation
- Ready and consistent text messaging access to participate
- Within 6-8 months of planned transfer to adult diabetes care
Exclusion Criteria:
- Other life-threatening disease (e.g. cancer) or major psychiatric disorder (e.g.
schizophrenia) that significantly limits participation
- Pervasive developmental disorder that significantly limits participation
We found this trial at
1
site
Click here to add this to my saved trials
