Type 1 DiabetesR34NCT02243072
Home-Based Interventions for Adolescents With Type 1 Diabetes
A study testing Fit Families plus Standard Medical Care in people with Type 1 Diabetes, run by Wayne State University at 1 site in United States.
Trial summary
Adolescents with T1D and chronic poor metabolic control are at high risk for short and long-term diabetes complications and are heavy users of both medical resources and health care dollars. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Fit Families plus Standard Medical Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Jul 2016
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- a current hemoglobin A1c(HbA1c) of >9.0%
- an average HbA1c of >9.0% during the past year
- reside in the metro Detroit tri-county area
- diagnosed with Type 1 diabetes for at least one year
- aged 10-17
- patient of Children's Hospital of Michigan Diabetes Clinic
Who cannot join
- severe mental impairment/thought disorder
- Active suicidality
- Active homicidality
- Diabetes secondary to another comorbid medical condition and/or medical management differing substantially from that of most children with diabetes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Michigan
Detroit, Michigan, 48201
About this study
Official title: Translating Home-Based Interventions for Adolescents With Poorly Controlled TID
Adolescents with T1D and chronic poor metabolic control are at high risk for short and long-term diabetes complications and are heavy users of both medical resources and health care dollars. The purpose of the proposed study is to collaborate with a community agency to develop and test an intervention, Fit Families, that uses the core components of a previously successful home-based family treatment, but that can delivered by lower cost community health workers. If successful, Fit Families could improve health outcomes in a vulnerable population at high risk for diabetes complications, and could be translated to real-world treatment settings.
Read the detailed description
The proposed study is a planning grant in which MST will be adapted for delivery by community health workers and will be conducted in collaboration with CHASS, a community agency providing health care to underserved residents of Detroit with diabetes. The new intervention, Fit Families (FF), will be tested in a pilot randomized controlled trial in order to evaluate FF feasibility, finalize outcome measures, estimate intervention effect sizes on health outcomes (i.e., youth adherence, glycemic control, quality of life) and determine potential cost savings associated with reduced hospital admissions. These steps will allow for finalization of intervention content and other trial parameters in preparation for a larger R18 dissemination trial.
The design for the proposed study is a randomized, controlled trial using a sample of 60 adolescents. Half will be randomly assigned to the treatment intervention, Fit Families plus standard medical care, and the other half will be assigned to standard medical care alone. Families who are randomized to FF receive intensive, home-based family therapy delivered by a community health worker (CHW) for approximately six months.
- Conditions
- Type 1 Diabetes
- Being tested
- Fit Families plus Standard Medical Care
- Keywords
- Insulin Dependent Diabetes Mellitus, family therapy, adolescents, regimen adherence, metabolic control
- 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.
Fit Families plus Standard Medical CareBehavioural
Adolescents will receive the Fit Families plus Standard Medical Care which consists of twice weekly home-based, family psychotherapy from a CHW for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Fit Familes plus Standard Medical Care | Experimental | Participants will receive the intervention Fit Families plus Standard Medical Care which is an adaptation of Multisystemic Therapy for Type 1 Diabetes delivered by Community Health Workers (CHWs) in addition to standard medical care. Receives: Behavioral: Fit Families plus Standard Medical Care |
| Standard Medical Care | No intervention | Standard medical care is provided at Children's Hospital of Michigan consistent with the standards for the care of children with T1D outlined by the American Diabetes Association. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Control: Hemoglobin A1c (HbA1c)
retrospective measure of blood glucose control, encompasses the previous 2-3 months
Measured: Change from Baseline at 7 months, Change from Baseline at 9 months
Secondary outcomes (3)
DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)
The number of patient visits to acute care settings represents a significant health care cost in this high-risk population.
Measured: Change from Baseline at 7 months, Change from Baseline at 9 months
Quality of life
44 scale item designed to tap life satisfaction, diabetes impact and diabetes related worries in adolescents.
Measured: Change from Baseline at 7 months, Change from Baseline at 9 months
Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads
The DMS assesses a broad range of management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision. Glucose meters only assess blood glucose monitoring, but are empirically linked to metabolic control
Measured: Change from Baseline at 7 months, Change from Baseline at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Ellis, Ph.D., Wayne State University
- Investigators
- Deborah A Ellis, Ph.D, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243072
- Sponsor's protocol ID
- 1R34DK102091-01
- Other IDs
- R34DK102091
- Acronym
- R34
- Status last verified
- Nov 2016
- First submitted
- 4 Sep 2014
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating Home-Based Interventions for Adolescents With Poorly Controlled TID
- ClinicalTrials.gov ID
- NCT02243072
- Acronym / sponsor ID
- R34 / 1R34DK102091-01
- Conditions
- Type 1 Diabetes
- Keywords
- Insulin Dependent Diabetes Mellitus, family therapy, adolescents, regimen adherence, metabolic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 17 Sep 2014 (estimated)
- 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.
Adolescents with T1D and chronic poor metabolic control are at high risk for short and long-term diabetes complications and are heavy users of both medical resources and health care dollars. The purpose of the proposed study is to collaborate with a community agency to develop and test an intervention, Fit Families, that uses the core components of a previously successful home-based family treatment, but that can delivered by lower cost community health workers. If successful, Fit Families could improve health outcomes in a vulnerable population at high risk for diabetes complications, and could be translated to real-world treatment settings.
Detailed description
The proposed study is a planning grant in which MST will be adapted for delivery by community health workers and will be conducted in collaboration with CHASS, a community agency providing health care to underserved residents of Detroit with diabetes. The new intervention, Fit Families (FF), will be tested in a pilot randomized controlled trial in order to evaluate FF feasibility, finalize outcome measures, estimate intervention effect sizes on health outcomes (i.e., youth adherence, glycemic control, quality of life) and determine potential cost savings associated with reduced hospital admissions. These steps will allow for finalization of intervention content and other trial parameters in preparation for a larger R18 dissemination trial.
The design for the proposed study is a randomized, controlled trial using a sample of 60 adolescents. Half will be randomly assigned to the treatment intervention, Fit Families plus standard medical care, and the other half will be assigned to standard medical care alone. Families who are randomized to FF receive intensive, home-based family therapy delivered by a community health worker (CHW) for approximately six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fit Familes plus Standard Medical Care | Experimental | Behavioral: Fit Families plus Standard Medical CareParticipants will receive the intervention Fit Families plus Standard Medical Care which is an adaptation of Multisystemic Therapy for Type 1 Diabetes delivered by Community Health Workers (CHWs) in addition to standard medical care. |
| Standard Medical Care | No intervention | –Standard medical care is provided at Children's Hospital of Michigan consistent with the standards for the care of children with T1D outlined by the American Diabetes Association. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- a current hemoglobin A1c(HbA1c) of >9.0%
- an average HbA1c of >9.0% during the past year
- reside in the metro Detroit tri-county area
- diagnosed with Type 1 diabetes for at least one year
- aged 10-17
Key exclusion criteria (4 listed)
- severe mental impairment/thought disorder
- Active suicidality
- Active homicidality
- Diabetes secondary to another comorbid medical condition and/or medical management differing substantially from that of most children with diabetes.
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 |
|---|---|---|
| Fit Families plus Standard Medical CareAdolescents will receive the Fit Families plus Standard Medical Care which consists of twice weekly home-based, family psychotherapy from a CHW for 6 months | Behavioural | Fit Familes plus Standard Medical Care |
Primary outcome
Metabolic Control: Hemoglobin A1c (HbA1c)
Time frame: Change from Baseline at 7 months, Change from Baseline at 9 months
retrospective measure of blood glucose control, encompasses the previous 2-3 months
3 secondary outcomes
DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)
Time frame: Change from Baseline at 7 months, Change from Baseline at 9 months
Quality of life
Time frame: Change from Baseline at 7 months, Change from Baseline at 9 months
Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads
Time frame: Change from Baseline at 7 months, Change from Baseline at 9 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 2 Jun 2017.
- 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.
Deborah A Ellis, Ph.D principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fit Families plus Standard Medical Care in people with Type 1 Diabetes, run by Wayne State University 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 6 inclusion and 4 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 2 Jun 2017. 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?
Metabolic Control: Hemoglobin A1c (HbA1c) (time frame: Change from Baseline at 7 months, Change from Baseline at 9 months). 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 2 Jun 2017.