Diabetes Mellitus, Type 1T1DALPilotNCT05234944
Pilot Study of Brief Intervention to Support Diabetes Health-Related Quality of Life
A study testing Type 1 Diabetes and Life in people with Diabetes Mellitus, Type 1, run by Baylor College of Medicine at 3 sites in United States.
Trial summary
The aims of this pilot study are to evaluate the feasibility, acceptability, preliminary impact, and costs of a brief, behavioral intervention delivered remotely by diabetes educators to people with type 1 diabetes and their family members. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Type 1 Diabetes and Life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Dec 2022to 1 Oct 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Type 1 diabetes diagnosis for at least 12 months
- Treated at the participating clinical site (for the pediatric and adult subspecialty sites)
- Fluent in English
- Age 18 years or older.
- Child/Partner with diabetes participating in study
- Fluent in English
Who cannot join
- Any major comorbid medical (PWD only), cognitive, or psychiatric condition that would limit ability to participate
- Plans to move to another clinical site during the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Baylor College of Medicine
Houston, Texas, 77030
Stanford University
Stanford, California, 94305
Joslin Diabetes Center at SUNY Upstate Medical University
Syracuse, New York, 13214
About this study
Official title: A Brief Telehealth Intervention to Address Diabetes Health-related Quality of Life (HRQOL) in Families of Youth and Adults with Type 1 Diabetes Across Clinical Settings: a Pilot and Feasibility Study
The aims of this pilot study are to evaluate the feasibility, acceptability, preliminary impact, and costs of a brief, behavioral intervention delivered remotely by diabetes educators to people with type 1 diabetes and their family members. The purpose of the intervention is to support health-related quality of life for people with type 1 diabetes of all ages and to support the diabetes health-related quality of life of their parents and partners. This pilot study will explore how this intervention works as a supplement to routine medical care in three clinical care settings: an adult specialty diabetes care setting, a pediatric subspecialty diabetes care setting, and for people who receive diabetes medical care from a primary care provider. To maximize data about feasibility and acceptability of the intervention, all participants in the pilot study will receive the intervention and there will not be randomization to a control condition.
Read the detailed description
The aims of this pilot study are to evaluate the feasibility, acceptability, preliminary impact, and costs of a brief behavioral intervention to support diabetes health-related quality of life, delivered remotely by diabetes educators to people with type 1 diabetes and their family members. The key components of the intervention include people with diabetes and their parents/partners completing a validated measure of diabetes-specific health-related quality of life around the time of two consecutive diabetes clinic appointments. A trained study certified diabetes care and education specialist (CDCES) will meet remotely (via secure, HIPAA-compliant cloud-based telehealth/videoconferencing platform) to guide the family in a brief discussion about each person's diabetes health-related quality of life. They will discuss the parts of quality of life that are going well and the parts that are more challenging, and the CDCES will teach brief behavioral strategies to address quality of life challenges. Using a non-randomized design, all participants will receive the intervention for the pilot study. Participants will complete surveys prior to receiving the intervention and again after the completion of the intervention, and clinical data will be collected from the person with diabetes and their medical records.
To evaluate this pilot intervention, the specific aims are: (1) Evaluate the feasibility and acceptability of the intervention for participants in three clinical settings: pediatric subspecialty clinic, adult specialty clinic, and diabetes care from primary care providers. (2) Examine preliminary indicators of pre-post change in behavioral and clinical outcomes. (3) Explore costs associated with intervention delivery and receipt to inform the next phases of intervention development and testing.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Type 1 Diabetes and Life
- Keywords
- behavioral intervention
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type 1 Diabetes and LifeBehavioural
Brief behavioral intervention, delivered remotely by certified diabetes care and education specialists, targeting diabetes-specific health-related quality of life for people with type 1 diabetes across the lifespan and for their parents and partners.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | A CDCES trained by the research team will deliver the intervention via HIPAA compliant telehealth/videoconferencing platform. There will be 2 sessions within approximately 6 months. Prior to each session, participants will complete an assessment of T1D-specific health-related quality of life, which will generate a summary report for each person that lists aspects of quality of life that are going well and aspects that are potential areas for improvement. The CDCES will review the reports with the participants, focusing on building on areas of strength and teaching brief behavioral strategies or resources to address aspects of quality of life that could be improved. Strategies may include stress management, problem-solving techniques, goal-setting, strategies to seek social support, or other brief behavioral skills. The CDCES will also offer information about relevant resources and will provide referrals for mental health support as needed. Receives: Behavioral: Type 1 Diabetes and Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of participant accrual, data collection, intervention delivery
Feasibility of conducting a research study about this intervention will be measured by percentage of eligible participants who consent to the study, complete questionnaires, and receive the full intervention dose. These outcomes will be calculated based on recruitment and program delivery tracking conducted by study staff
Measured: Post-intervention, up to 6 months
Acceptability
Participants will complete brief surveys at study completion that assess their experiences with the intervention, including helpfulness of conversations, value of time spent, overall acceptability of program, and recommendations for improvement. Items will be rated using a Likert-scale, with higher scores indicating higher satisfaction with each item.
Measured: Post-intervention, up to 6 months
Secondary outcomes (5)
Diabetes health-related quality of life
Participants will complete the age- and respondent-appropriate version of the Type 1 Diabetes and Life (T1DAL) measure. Psychometric data regarding the validity and reliability of the pediatric, adult, and parent/partner versions of the T1DAL are published. Total scores are on a 100-point scale, with higher scores indicating better quality of life.
This is the only measure that will also be collected at the mid-point (before 2nd visit) between the two intervention sessions. Participant responses on the baseline and midpoint T1DAL measures will be automatically scored (per an algorithm designed by the study investigator team) and used to generate a quality of life profile that the CDCES will use in each intervention session.
Measured: Baseline and Post-intervention, up to 6 months
Diabetes distress
Participants will complete the age- and respondent-appropriate version of the Problem Areas in Diabetes (PAID) scale (children, adolescents, and parents) or the Diabetes Distress Scale (adults and partners). Higher scores on each measure indicate more distress.
Measured: Baseline and Post-intervention, up 6 months
Adherence/Diabetes Self-management
Participants will complete the Self-Care Inventory Revised. Higher scores indicate higher adherence/more engagement in diabetes self-management behaviors. For youth under age 12, parents will complete this measure about the child's self-management behaviors because this measure has not been validated for self-report use by children. Parents of youth age 12 or older and partners of adults will not complete any measures of self-management behavior.
Measured: Baseline and Post-intervention, up to 6 months
Glycemic Outcome - HbA1c
Point of care HbA1c values documented by the medical team at each clinic visit during which an intervention session takes place, plus the following clinic visit (3-6 months after the second intervention session) will be collected from the electronic health record, to assess change in glycemic outcomes. For participants in the primary care group, participants will self-report the date and value of their most recent HbA1c at each time point. They will be asked to upload a photo/PDF of documentation of their HbA1c value (e.g., lab results printout) if available. Participants in the primary care group will also be asked to complete a research home fingerstick HbA1c kit. Higher HbA1c indicates higher average blood glucose values over the previous 2-3 months, which represents poorer glycemic control.
Measured: Baseline and Post-intervention, up to 6 months
Glycemic Outcome - Time in Range
When available for participants who use a continuous glucose monitor (CGM), 14 days' of CGM data will be downloaded at each time point by the study teams to calculate glucose time-in-range as an additional index of glycemic control. Higher time-in-range is an indicator of better glycemic control.
Measured: Baseline and Post-intervention, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start9 Dec 2022
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Non-randomized pilot study, all participants will receive intervention
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Responsible party
- Principal investigator, Marisa Hilliard, Baylor College of Medicine
- Investigators
- Marisa Hilliard, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234944
- Sponsor's protocol ID
- H-50359
- Acronym
- T1DALPilot
- Status last verified
- Oct 2024
- First submitted
- 1 Feb 2022
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share de-identified data for all IPD that underlie results in a publication on request
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Telehealth Intervention to Address Diabetes Health-related Quality of Life (HRQOL) in Families of Youth and Adults with Type 1 Diabetes Across Clinical Settings: a Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT05234944
- Acronym / sponsor ID
- T1DALPilot / H-50359
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 10 Feb 2022 (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 aims of this pilot study are to evaluate the feasibility, acceptability, preliminary impact, and costs of a brief, behavioral intervention delivered remotely by diabetes educators to people with type 1 diabetes and their family members. The purpose of the intervention is to support health-related quality of life for people with type 1 diabetes of all ages and to support the diabetes health-related quality of life of their parents and partners. This pilot study will explore how this intervention works as a supplement to routine medical care in three clinical care settings: an adult specialty diabetes care setting, a pediatric subspecialty diabetes care setting, and for people who receive diabetes medical care from a primary care provider. To maximize data about feasibility and acceptability of the intervention, all participants in the pilot study will receive the intervention and there will not be randomization to a control condition.
Detailed description
The aims of this pilot study are to evaluate the feasibility, acceptability, preliminary impact, and costs of a brief behavioral intervention to support diabetes health-related quality of life, delivered remotely by diabetes educators to people with type 1 diabetes and their family members. The key components of the intervention include people with diabetes and their parents/partners completing a validated measure of diabetes-specific health-related quality of life around the time of two consecutive diabetes clinic appointments. A trained study certified diabetes care and education specialist (CDCES) will meet remotely (via secure, HIPAA-compliant cloud-based telehealth/videoconferencing platform) to guide the family in a brief discussion about each person's diabetes health-related quality of life. They will discuss the parts of quality of life that are going well and the parts that are more challenging, and the CDCES will teach brief behavioral strategies to address quality of life challenges. Using a non-randomized design, all participants will receive the intervention for the pilot study. Participants will complete surveys prior to receiving the intervention and again after the completion of the intervention, and clinical data will be collected from the person with diabetes and their medical records.
To evaluate this pilot intervention, the specific aims are: (1) Evaluate the feasibility and acceptability of the intervention for participants in three clinical settings: pediatric subspecialty clinic, adult specialty clinic, and diabetes care from primary care providers. (2) Examine preliminary indicators of pre-post change in behavioral and clinical outcomes. (3) Explore costs associated with intervention delivery and receipt to inform the next phases of intervention development and testing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomized pilot study, all participants will receive intervention
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Type 1 Diabetes and LifeA CDCES trained by the research team will deliver the intervention via HIPAA compliant telehealth/videoconferencing platform. There will be 2 sessions within approximately 6 months. Prior to each session, participants will complete an assessment of T1D-specific health-related quality of life, which will generate a summary report for each person that lists aspects of quality of life that are going well and aspects that are potential areas for improvement. The CDCES will review the reports with the participants, focusing on building on areas of strength and teaching brief behavioral strategies or resources to address aspects of quality of life that could be improved. Strategies may include stress management, problem-solving techniques, goal-setting, strategies to seek social support, or other brief behavioral skills. The CDCES will also offer information about relevant resources and will provide referrals for mental health support as needed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Type 1 diabetes diagnosis for at least 12 months
- Treated at the participating clinical site (for the pediatric and adult subspecialty sites)
- Fluent in English
- Age 18 years or older.
- Child/Partner with diabetes participating in study
Key exclusion criteria (2 listed)
- Any major comorbid medical (PWD only), cognitive, or psychiatric condition that would limit ability to participate
- Plans to move to another clinical site during 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 |
|---|---|---|
| Type 1 Diabetes and LifeBrief behavioral intervention, delivered remotely by certified diabetes care and education specialists, targeting diabetes-specific health-related quality of life for people with type 1 diabetes across the lifespan and for their parents and partners. | Behavioural | Intervention |
Primary outcome
Feasibility of participant accrual, data collection, intervention delivery
Time frame: Post-intervention, up to 6 months
Feasibility of conducting a research study about this intervention will be measured by percentage of eligible participants who consent to the study, complete questionnaires, and receive the full intervention dose. These outcomes will be calculated based on recruitment and program delivery tracking conducted by study staff
Acceptability
Time frame: Post-intervention, up to 6 months
Participants will complete brief surveys at study completion that assess their experiences with the intervention, including helpfulness of conversations, value of time spent, overall acceptability of program, and recommendations for improvement. Items will be rated using a Likert-scale, with higher scores indicating higher satisfaction with each item.
5 secondary outcomes
Diabetes health-related quality of life
Time frame: Baseline and Post-intervention, up to 6 months
Diabetes distress
Time frame: Baseline and Post-intervention, up 6 months
Adherence/Diabetes Self-management
Time frame: Baseline and Post-intervention, up to 6 months
Glycemic Outcome - HbA1c
Time frame: Baseline and Post-intervention, up to 6 months
Glycemic Outcome - Time in Range
Time frame: Baseline and Post-intervention, up to 6 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 10 Oct 2024.
- Individual participant dataSharing planned: Yes. The investigators will share de-identified data for all IPD that underlie results in a publication on request
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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.
Marisa Hilliard, PhD principal investigator
Baylor College of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Type 1 Diabetes and Life in people with Diabetes Mellitus, Type 1, run by Baylor College of Medicine at 3 sites 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 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Feasibility of participant accrual, data collection, intervention delivery (time frame: Post-intervention, up to 6 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?
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 10 Oct 2024.