Diabetes MellitusNCT04600622
Adapting and Assessing the Feasibility of a Diabetes Self-management Telehealth Intervention
A study testing Rural Diabetes One-Day Education and Care program (R-D1D) and Diabetes Education Materials in people with Diabetes Mellitus, run by University of Utah at 1 site in United States.
Trial summary
The proposed project will use community based participatory research to adapt an existing diabetes self-management and education intervention with a telehealth intervention to be culturally relevant for rural English- and Spanish-speaking populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Rural Diabetes One-Day Education and Care program (R-D1D) and Diabetes Education Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2021to 24 Aug 2022
- 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
- Have a known diagnosis of type 1 or 2 diabetes with any A1C level
- 18 years old or older
- Live in a rural eastern Colorado
- Speak and understand English or Spanish
- Willing to participate in a telehealth intervention at the clinic where they usually receive care or in their own home if an in-person meeting is prohibited due to the pandemic
Who cannot join
- Are participating in another diabetes study
- Significant cognitive impairment
- Pregnant or planning to become pregnant as diabetes management recommendations are different in pregnancy
- Life expectancy of <6 months
- Plan to move during the time of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Denver, Colorado, 80204
About this study
Official title: Adapting and Assessing the Feasibility of a Diabetes Self-management Education and Support Telehealth Intervention for Rural Populations to Reduce Disparities in Diabetes Care
The proposed project will use community based participatory research to adapt an existing diabetes self-management and education intervention with a telehealth intervention to be culturally relevant for rural English- and Spanish-speaking populations. Participants and care partners will receive a one-time, 5.5-hour telehealth intervention from a multidisciplinary team specializing in diabetes. The overarching aim of this study is to provide a sustainable model to provide diabetes specialty care to rural populations.
Read the detailed description
Diabetes prevalence is higher in rural areas that have lower resources to diabetes self-management education and support (DSMES), a cornerstone to optimal diabetes management. A time efficient DSMES program delivered via telehealth by multidisciplinary experts that also encourages care partner and peer support is a creative solution to increasing access to DSMES and reducing disparities. This study is guided by the Research, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. English and Spanish-speaking participants and care partners will receive a one-time, 8-hour telehealth intervention at the rural clinic where they receive their usual care, from the multidisciplinary team. The rural clinical practices will provide feedback in two rounds, with iterative practice-level changes, to address process and/or workflow issues. Our overall objective is to adapt, implement, refine, and evaluate a time efficient DSMES program delivered via telehealth by a team of multidisciplinary experts that encourages care partner and peer support to improve A1C and diabetes self-management in rural communities to reduce disparities. Our multidisciplinary team includes researchers and clinical healthcare providers with experience in diabetes care, DSMES delivery, community-engaged research, practice-based research, and rural health issues. The University of Utah and High Plains Research Network provide a strong environment for this particular study. The proposed study will 1) adapt the exiting Diabetes One-Day Program (D1D) for use in rural communities (Rural Diabetes One-Day Program or R-D1D), 2) conduct a patient-level pilot RCT to examine effects of R-D1D (intervention group) versus standard patient education (attention control group), guided by the RE-AIM framework. Our ultimate goal is to reduce health disparities in rural populations by increasing access to diabetes specialty care using telehealth. Preliminary data support the D1D intervention, but will require adaptation to translate for rural populations, then iterative refinement at the practice level to support long-term maintenance. Such a tested, accepted intervention should have a beneficial effect on diabetes self-management across multiple rural locations.
- Conditions
- Diabetes Mellitus
- Being tested
- Rural Diabetes One-Day Education and Care program (R-D1D), Diabetes Education Materials
- Keywords
- diabetes, telehealth, rural, Spanish, English, community based participatory research
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rural Diabetes One-Day Education and Care program (R-D1D)Behavioural
One time, 5.5-hour multi-disciplinary diabetes self-management education and support intervention delivered via telehealth.
Diabetes Education MaterialsBehavioural
Diabetes Education Materials
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants will receive Rural Diabetes One-Day Education and Care program (R-D1D). A one time, 5.5-hour multi-disciplinary diabetes self-management education and support intervention delivered via telehealth. Receives: Behavioral: Rural Diabetes One-Day Education and Care program (R-D1D) |
| Active Comparator | Active comparator | Participants will receive diabetes education materials. Receives: Behavioral: Diabetes Education Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Acceptability Score
Average acceptability score on the intervention acceptability measure
Measured: 3 months
Average Feasibility Score
Average feasibility score on the feasibility measure
Measured: 3 months
Secondary outcomes (3)
Change in glycosylated hemoglobin A1C
Physiologic measurement
Measured: Baseline to 3 months
Change in diabetes distress score
The patient reported, 20-item, Problem Areas in Diabetes survey will be used.
Measured: Baseline to 3 months
Change in Family and Friend Involvement in Diabetes score
The patient reported, 16-item, Family and Friend Involvement in Diabetes survey will be used.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start17 Jun 2021
- Primary completion8 Apr 2022
- Study completion24 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Principal investigator, Michelle Litchman, University of Utah
- Investigators
- Michelle L Litchman, PhD, Principal investigator, University of Utah College of NursingTamara K Oser, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600622
- Sponsor's protocol ID
- 00133179
- Status last verified
- Aug 2023
- First submitted
- 15 Oct 2020
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Litchman ML, Kwan BM, Zittleman L, Simonetti J, Iacob E, Curcija K, Neuberger J, Latendress G, Oser TK. A Telehealth Diabetes Intervention for Rural Populations: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Jun 14;11(6):e34255. doi: 10.2196/34255.
PubMed 35700026
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting and Assessing the Feasibility of a Diabetes Self-management Education and Support Telehealth Intervention for Rural Populations to Reduce Disparities in Diabetes Care
- ClinicalTrials.gov ID
- NCT04600622
- Acronym / sponsor ID
- 00133179
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes, telehealth, rural, Spanish, English, community based participatory research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 23 Oct 2020 (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 project will use community based participatory research to adapt an existing diabetes self-management and education intervention with a telehealth intervention to be culturally relevant for rural English- and Spanish-speaking populations. Participants and care partners will receive a one-time, 5.5-hour telehealth intervention from a multidisciplinary team specializing in diabetes. The overarching aim of this study is to provide a sustainable model to provide diabetes specialty care to rural populations.
Detailed description
Diabetes prevalence is higher in rural areas that have lower resources to diabetes self-management education and support (DSMES), a cornerstone to optimal diabetes management. A time efficient DSMES program delivered via telehealth by multidisciplinary experts that also encourages care partner and peer support is a creative solution to increasing access to DSMES and reducing disparities. This study is guided by the Research, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. English and Spanish-speaking participants and care partners will receive a one-time, 8-hour telehealth intervention at the rural clinic where they receive their usual care, from the multidisciplinary team. The rural clinical practices will provide feedback in two rounds, with iterative practice-level changes, to address process and/or workflow issues. Our overall objective is to adapt, implement, refine, and evaluate a time efficient DSMES program delivered via telehealth by a team of multidisciplinary experts that encourages care partner and peer support to improve A1C and diabetes self-management in rural communities to reduce disparities. Our multidisciplinary team includes researchers and clinical healthcare providers with experience in diabetes care, DSMES delivery, community-engaged research, practice-based research, and rural health issues. The University of Utah and High Plains Research Network provide a strong environment for this particular study. The proposed study will 1) adapt the exiting Diabetes One-Day Program (D1D) for use in rural communities (Rural Diabetes One-Day Program or R-D1D), 2) conduct a patient-level pilot RCT to examine effects of R-D1D (intervention group) versus standard patient education (attention control group), guided by the RE-AIM framework. Our ultimate goal is to reduce health disparities in rural populations by increasing access to diabetes specialty care using telehealth. Preliminary data support the D1D intervention, but will require adaptation to translate for rural populations, then iterative refinement at the practice level to support long-term maintenance. Such a tested, accepted intervention should have a beneficial effect on diabetes self-management across multiple rural locations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Rural Diabetes One-Day Education and Care program (R-D1D)Participants will receive Rural Diabetes One-Day Education and Care program (R-D1D). A one time, 5.5-hour multi-disciplinary diabetes self-management education and support intervention delivered via telehealth. |
| Active Comparator | Active comparator | Behavioral: Diabetes Education MaterialsParticipants will receive diabetes education materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a known diagnosis of type 1 or 2 diabetes with any A1C level
- 18 years old or older
- Live in a rural eastern Colorado
- Speak and understand English or Spanish
- Willing to participate in a telehealth intervention at the clinic where they usually receive care or in their own home if an in-person meeting is prohibited due to the pandemic
Key exclusion criteria (5 listed)
- Are participating in another diabetes study
- Significant cognitive impairment
- Pregnant or planning to become pregnant as diabetes management recommendations are different in pregnancy
- Life expectancy of <6 months
- Plan to move during the time of the study
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 |
|---|---|---|
| Rural Diabetes One-Day Education and Care program (R-D1D)One time, 5.5-hour multi-disciplinary diabetes self-management education and support intervention delivered via telehealth. | Behavioural | Intervention Arm |
| Diabetes Education MaterialsDiabetes Education Materials | Behavioural | Active Comparator |
Primary outcome
Average Acceptability Score
Time frame: 3 months
Average acceptability score on the intervention acceptability measure
Average Feasibility Score
Time frame: 3 months
Average feasibility score on the feasibility measure
3 secondary outcomes
Change in glycosylated hemoglobin A1C
Time frame: Baseline to 3 months
Change in diabetes distress score
Time frame: Baseline to 3 months
Change in Family and Friend Involvement in Diabetes score
Time frame: Baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Derived from this study: PubMed 35700026Litchman ML, Kwan BM, Zittleman L, Simonetti J, Iacob E, Curcija K, Neuberger J, Latendress G, Oser TK. A Telehealth Diabetes Intervention for Rural Populations: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Jun 14;11(6):e34255. doi: 10.2196/34255.
- 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.
Michelle L Litchman, PhD principal investigator
University of Utah College of Nursing
Tamara K Oser, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rural Diabetes One-Day Education and Care program (R-D1D) and Diabetes Education Materials in people with Diabetes Mellitus, run by University of Utah 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 5 inclusion and 5 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 31 Aug 2023. 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?
Average Acceptability Score (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT04600622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.