Diabetes MellitusNCT03023228
Diabetes To Go: An Inpatient Diabetes Survival Skills Education Program
A study testing diabetes self-management education in people with Diabetes Mellitus and Hyperglycemia, run by Medstar Health Research Institute.
Trial summary
A learner-centered diabetes survival skills self-management education program was provided to adults with uncontrolled diabetes in the hospital and generated preliminary evidence of impact on medication adherence and a trend toward reduction in hospital and emergency department admissions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Hyperglycemia
- What is being tested?
- diabetes self-management education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Nov 2011
- 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
- English speaking with a diabetes mellitus diagnosis (ICD 9 codes 250.xx)
- an admitting blood glucose level of > 200 mg/dL or ≤ 40 mg/dL, and
- an anticipated hospital stay of ≥ 2 days, as estimated by the medical staff, to allow sufficient time for delivery of program content
Who cannot join
- pregnancy
- admission to an intensive care unit, and
- any medical condition or cognitive dysfunction that, in the opinion of the investigator, would preclude active participation
About this study
Official title: Diabetes To Go: A Pilot Feasibility and Preliminary Efficacy Evaluation of an Inpatient Diabetes Self-management Survival Skills Education Program
A learner-centered diabetes survival skills self-management education program was provided to adults with uncontrolled diabetes in the hospital and generated preliminary evidence of impact on medication adherence and a trend toward reduction in hospital and emergency department admissions.
Read the detailed description
This study was a prospective, nonrandomized pilot study conducted among adults with uncontrolled diabetes admitted to the Medicine Service of an urban tertiary teaching hospital were consented to participate in a pilot study which provided diabetes survival skills education. Based on knowledge deficits identified on a diabetes knowledge pre-test the patient was directed to view video content corresponding to those deficiencies and content on sick days and diabetes complications. Evaluation measures were diabetes knowledge, medication adherence, and hospital admissions plus emergency department visits at and/or 3months before baseline and at 2 weeks and 3 months post-discharge. There was improvement in diabetes knowledge and medication adherence, which was sustained to 3 months. A trend was observed toward reduction in emergency department and/or hospital admissions from 3 months pre-intervention to 3 months post-discharge for uncontrolled diabetes. This knowledge-based program successfully provided survival skills education to hospital patients with uncontrolled diabetes and demonstrated preliminary evidence of a positive impact on medication adherence and a trend toward reduction in hospital and emergency department admissions.
- Conditions
- Diabetes Mellitus, Hyperglycemia
- Being tested
- diabetes self-management education
- Keywords
- Diabetes mellitus, Hyperglycemia, Inpatient, self-management education
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diabetes self-management educationBehavioural
Also called survival skills education
1-group, pre-test/post-test design feasibility and preliminary efficacy evaluation of diabetes survival skills self-management education delivered at the hospital bedside.
| Study group | Role | What they receive |
|---|---|---|
| diabetes self-management education | Experimental | Diabetes survival skills self-management education (DSME) program content was aligned with American Diabetes Association and Joint Commission suggested key areas for hospital diabetes education. Content areas were as follows: when and how to take diabetes medications; glycemic goals and self-blood glucose monitoring; definition, prevention, recognition, and treatment of hypoglycemia and hyperglycemia; what to do before you see the dietitian; sick day management; and when to call the doctor or go to the ED. Program content was created for delivery via either DVD or print format. Receives: Behavioral: diabetes self-management education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change in Diabetes knowledge as measured by an 11-item diabetes knowledge survey
11-item diabetes knowledge survey administered pre- and post- education intervention during the same hospital stay. Baseline score and post intervention score obtained within a 24 hour period
Measured: Baseline score obtained before receiving the education intervention. Post test score obtained immediately after the education intervention was completed during the hospital stay, usually within 24 hours or less from the baseline score
Secondary outcomes (2)
Readmissions to the hospital and the emergency department
Self-reported historic and post-intervention visits to ED and or admissions to the hospital
Measured: 3 months pre- and 3 months post-intervention
Medication adherence (Modified Morisky Medication Adherence Scale 4-item)
Modified Morisky Medication Adherence Scale 4-item
Measured: Baseline pre intervention then at 2 weeks after intervention and at 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startMay 2010
- Primary completionNov 2011
- Study completionNov 2011
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.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- michelle f magee, MD, MBBCh,, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023228
- Sponsor's protocol ID
- 2009-354
- Status last verified
- Jan 2017
- First submitted
- 4 May 2015
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Magee MF, Khan NH, Desale S, Nassar CM. Diabetes to Go: Knowledge- and Competency-Based Hospital Survival Skills Diabetes Education Program Improves Postdischarge Medication Adherence. Diabetes Educ. 2014 May;40(3):344-350. doi: 10.1177/0145721714523684. Epub 2014 Feb 20.
PubMed 24557596
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes To Go: A Pilot Feasibility and Preliminary Efficacy Evaluation of an Inpatient Diabetes Self-management Survival Skills Education Program
- ClinicalTrials.gov ID
- NCT03023228
- Acronym / sponsor ID
- 2009-354
- Conditions
- Diabetes Mellitus, Hyperglycemia
- Keywords
- Diabetes mellitus, Hyperglycemia, Inpatient, self-management education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- May 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 18 Jan 2017 (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.
A learner-centered diabetes survival skills self-management education program was provided to adults with uncontrolled diabetes in the hospital and generated preliminary evidence of impact on medication adherence and a trend toward reduction in hospital and emergency department admissions.
Detailed description
This study was a prospective, nonrandomized pilot study conducted among adults with uncontrolled diabetes admitted to the Medicine Service of an urban tertiary teaching hospital were consented to participate in a pilot study which provided diabetes survival skills education. Based on knowledge deficits identified on a diabetes knowledge pre-test the patient was directed to view video content corresponding to those deficiencies and content on sick days and diabetes complications. Evaluation measures were diabetes knowledge, medication adherence, and hospital admissions plus emergency department visits at and/or 3months before baseline and at 2 weeks and 3 months post-discharge. There was improvement in diabetes knowledge and medication adherence, which was sustained to 3 months. A trend was observed toward reduction in emergency department and/or hospital admissions from 3 months pre-intervention to 3 months post-discharge for uncontrolled diabetes. This knowledge-based program successfully provided survival skills education to hospital patients with uncontrolled diabetes and demonstrated preliminary evidence of a positive impact on medication adherence and a trend toward reduction in hospital and emergency department admissions.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diabetes self-management education | Experimental | Behavioral: diabetes self-management educationDiabetes survival skills self-management education (DSME) program content was aligned with American Diabetes Association and Joint Commission suggested key areas for hospital diabetes education. Content areas were as follows: when and how to take diabetes medications; glycemic goals and self-blood glucose monitoring; definition, prevention, recognition, and treatment of hypoglycemia and hyperglycemia; what to do before you see the dietitian; sick day management; and when to call the doctor or go to the ED. Program content was created for delivery via either DVD or print format. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English speaking with a diabetes mellitus diagnosis (ICD 9 codes 250.xx)
- an admitting blood glucose level of > 200 mg/dL or ≤ 40 mg/dL, and
- an anticipated hospital stay of ≥ 2 days, as estimated by the medical staff, to allow sufficient time for delivery of program content
Key exclusion criteria (3 listed)
- pregnancy
- admission to an intensive care unit, and
- any medical condition or cognitive dysfunction that, in the opinion of the investigator, would preclude active participation
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 |
|---|---|---|
| diabetes self-management educationAlso: survival skills education1-group, pre-test/post-test design feasibility and preliminary efficacy evaluation of diabetes survival skills self-management education delivered at the hospital bedside. | Behavioural | diabetes self-management education |
Primary outcome
Assessment of change in Diabetes knowledge as measured by an 11-item diabetes knowledge survey
Time frame: Baseline score obtained before receiving the education intervention. Post test score obtained immediately after the education intervention was completed during the hospital stay, usually within 24 hours or less from the baseline score
11-item diabetes knowledge survey administered pre- and post- education intervention during the same hospital stay. Baseline score and post intervention score obtained within a 24 hour period
2 secondary outcomes
Readmissions to the hospital and the emergency department
Time frame: 3 months pre- and 3 months post-intervention
Medication adherence (Modified Morisky Medication Adherence Scale 4-item)
Time frame: Baseline pre intervention then at 2 weeks after intervention and at 3 months post-intervention
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 18 Aug 2020.
- Results publication: PubMed 24557596Magee MF, Khan NH, Desale S, Nassar CM. Diabetes to Go: Knowledge- and Competency-Based Hospital Survival Skills Diabetes Education Program Improves Postdischarge Medication Adherence. Diabetes Educ. 2014 May;40(3):344-350. doi: 10.1177/0145721714523684. Epub 2014 Feb 20.
- 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 f magee, MD, MBBCh, principal investigator
Medstar Health Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing diabetes self-management education in people with Diabetes Mellitus and Hyperglycemia, run by Medstar Health Research Institute.
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 3 inclusion and 3 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 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Assessment of change in Diabetes knowledge as measured by an 11-item diabetes knowledge survey (time frame: Baseline score obtained before receiving the education intervention. Post test score obtained immediately after the education intervention was completed during the hospital stay, usually within 24 hours or less from the baseline score). 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 NCT03023228, 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 18 Aug 2020.