Diabetes Mellitus Type 2NCT00119041
Diabetes Telemedicine Consultation: A Systems Improvement Intervention
A study testing The Diabetes Treatment Satisfaction Questionnaire, Diabetes Empowerment Scale and CBOC's undergo half-day joint-clinics via teleconference in people with Diabetes Mellitus Type 2 and Diabetes Mellitus, Type 1, run by US Department of Veterans Affairs at 2 sites in United States.
Trial summary
This study seeks to evaluate and document the processes of outreach consultation through joint-clinics via teleconferencing as an intervention for system improvement in care delivery and management of diabetes mellitus (DM) at a Community Based Outpatient Center (CBOCs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2, Diabetes Mellitus, Type 1, Primary Care Provider
- What is being tested?
- The Diabetes Treatment Satisfaction Questionnaire, Diabetes Empowerment Scale and CBOC's undergo half-day joint-clinics via teleconference
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2005to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 1) Current prescription of insulin or an oral hypoglycemic agent
- 2) A1c > 7.0%
- 3) fasting glucose levels > 130 mg/dl
- 4) referred to see a consultant and are seen during the active intervention phase. Patients with either Type I or Type II DM will be included
- A Primary Care Provider for a Cleveland CBOC
Who cannot join
- 1) primary care obtained at more than one site (based on stop codes with evidence of more than 1 CBOC involved in care during the last 6 months)
- 2) documented dementia, aphasia, and psychosis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48113-0170
Louis Stokes VA Medical Center
Cleveland, Ohio, 44106-3800
About this study
This study seeks to evaluate and document the processes of outreach consultation through joint-clinics via teleconferencing as an intervention for system improvement in care delivery and management of diabetes mellitus (DM) at a Community Based Outpatient Center (CBOCs).
Read the detailed description
Background:
Diabetes is a national problem that has reached epidemic proportions, according to the U.S. Centers for Disease Control and Prevention. Diabetes has particular importance for the Department of Veterans Affairs (VA) because the prevalence among VA patients -- one in six, or 16 percent -- is substantially higher than in the general population.
Objectives:
The objective of this study was to evaluate and document the processes of outreach consultation through the use of joint-clinics via teleconferencing as an intervention for system improvement in care delivery and management of diabetes at CBOCs. The intervention consisted of a teleconferenced joint-clinic consultation session involving the patient, Diabetes Specialist Team, the Primary Care Provider (PCP) and other relevant care team members. The impact of the 16-month intervention was assessed based on patients who were involved in the telemedicine clinic and those who were referred to a specialist to be seen on-site at the Cleveland VAMC.
Methods:
Study settings include the CBOCs affiliated with the Cleveland Veterans Affairs Medical Center (VAMC) and involve primary care referrals to see diabetes specialists at the Cleveland VAMC. Inclusion criteria patients(N 282)=included: (i) current prescription of insulin or an oral hypoglycemic agent; (ii) A1c > 7.0%; or (iii) fasting glucose levels> 130 mg/dl; and (iv) referred to see a consultant (beginning three months prior to the active intervention phase and continuing through enrollment for the last month of the active intervention phase). Patients with either Type l or Type II diabetes will be included. Patients referred will be contacted and asked to participate.
- Being tested
- The Diabetes Treatment Satisfaction Questionnaire, Diabetes Empowerment Scale, CBOC's undergo half-day joint-clinics via teleconference
- Keywords
- Diabetes Mellitus, Telemedicine, Referral, Consultation
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Diabetes Treatment Satisfaction QuestionnaireBehavioural
A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.
Diabetes Empowerment ScaleBehavioural
A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.
CBOC's undergo half-day joint-clinics via teleconferenceBehavioural
A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine CBOC | Experimental | Designated CBOC's were involved in the intervention phase where their Diabetes Mellitus (DM) patients were asked to participate in a telemedicine visit.
The Behavioral: The Diabetes Treatment Satisfaction Questionnaire given during this phase along with the Behavioral: Diabetes Empowerment Scale and the Behavioral: CBOC's undergo half-day joint-clinics via teleconference. Receives: Behavioral: The Diabetes Treatment Satisfaction Questionnaire; Behavioral: Diabetes Empowerment Scale; Behavioral: CBOC's undergo half-day joint-clinics via teleconference |
| Control CBOC | No intervention | The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education. |
| Provider Interviews | No intervention | Qualitative interviews with providers |
What is being measured
The primary outcome is the main question the study is designed to answer.
A1c
Hemoglobin A1c is a measure of glycemic control
Measured: baseline and 18 months
Secondary outcomes (1)
Patient Satisfaction
Diabetes Treatment Satisfaction Questionnaire (DTSQ) consists of 6 questions and ranges from 0-6. The following aspects of current treatment included were convenience, flexibility, understanding and continuing present form of treatment. The total range of the DTSQ is the sum of the 6 individual questions scores (i.e. 0-36) Higher scores represent greater satisfaction/convenience.
Measured: Base line and at18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David C Aron, MD MS, Principal investigator, Louis Stokes VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119041
- Sponsor's protocol ID
- IIR 03-254
- Status last verified
- May 2015
- First submitted
- 1 Jul 2005
- Last updated
- 15 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tomolo AM, Lawrence RH, Aron DC. A case study of translating ACGME practice-based learning and improvement requirements into reality: systems quality improvement projects as the key component to a comprehensive curriculum. Qual Saf Health Care. 2009 Jun;18(3):217-24. doi: 10.1136/qshc.2007.024729.
PubMed 19468006Pogach L, Aron D. Balancing hypoglycemia and glycemic control: a public health approach for insulin safety. JAMA. 2010 May 26;303(20):2076-7. doi: 10.1001/jama.2010.655. No abstract available.
PubMed 20501929F O Kern E, Beischel S, Stalnaker R, Aron DC, Kirsh SR, Watts SA. Building a diabetes registry from the Veterans Health Administration's computerized patient record system. J Diabetes Sci Technol. 2008 Jan;2(1):7-14. doi: 10.1177/193229680800200103.
PubMed 19885172
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Telemedicine Consultation: A Systems Improvement Intervention
- ClinicalTrials.gov ID
- NCT00119041
- Acronym / sponsor ID
- IIR 03-254
- Keywords
- Diabetes Mellitus, Telemedicine, Referral, Consultation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Sep 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 12 Jul 2005 (estimated)
- Results
- Posted 12 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to evaluate and document the processes of outreach consultation through joint-clinics via teleconferencing as an intervention for system improvement in care delivery and management of diabetes mellitus (DM) at a Community Based Outpatient Center (CBOCs).
Detailed description
Background:
Diabetes is a national problem that has reached epidemic proportions, according to the U.S. Centers for Disease Control and Prevention. Diabetes has particular importance for the Department of Veterans Affairs (VA) because the prevalence among VA patients -- one in six, or 16 percent -- is substantially higher than in the general population.
Objectives:
The objective of this study was to evaluate and document the processes of outreach consultation through the use of joint-clinics via teleconferencing as an intervention for system improvement in care delivery and management of diabetes at CBOCs. The intervention consisted of a teleconferenced joint-clinic consultation session involving the patient, Diabetes Specialist Team, the Primary Care Provider (PCP) and other relevant care team members. The impact of the 16-month intervention was assessed based on patients who were involved in the telemedicine clinic and those who were referred to a specialist to be seen on-site at the Cleveland VAMC.
Methods:
Study settings include the CBOCs affiliated with the Cleveland Veterans Affairs Medical Center (VAMC) and involve primary care referrals to see diabetes specialists at the Cleveland VAMC. Inclusion criteria patients(N 282)=included: (i) current prescription of insulin or an oral hypoglycemic agent; (ii) A1c > 7.0%; or (iii) fasting glucose levels> 130 mg/dl; and (iv) referred to see a consultant (beginning three months prior to the active intervention phase and continuing through enrollment for the last month of the active intervention phase). Patients with either Type l or Type II diabetes will be included. Patients referred will be contacted and asked to participate.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Telemedicine CBOC | Experimental | Behavioral: The Diabetes Treatment Satisfaction Questionnaire, Behavioral: Diabetes Empowerment Scale, Behavioral: CBOC's undergo half-day joint-clinics via teleconferenceDesignated CBOC's were involved in the intervention phase where their Diabetes Mellitus (DM) patients were asked to participate in a telemedicine visit. The Behavioral: The Diabetes Treatment Satisfaction Questionnaire given during this phase along with the Behavioral: Diabetes Empowerment Scale and the Behavioral: CBOC's undergo half-day joint-clinics via teleconference. |
| Control CBOC | No intervention | –The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education. |
| Provider Interviews | No intervention | –Qualitative interviews with providers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1) Current prescription of insulin or an oral hypoglycemic agent
- 2) A1c > 7.0%
- 3) fasting glucose levels > 130 mg/dl
- 4) referred to see a consultant and are seen during the active intervention phase. Patients with either Type I or Type II DM will be included
- A Primary Care Provider for a Cleveland CBOC
Key exclusion criteria (2 listed)
- 1) primary care obtained at more than one site (based on stop codes with evidence of more than 1 CBOC involved in care during the last 6 months)
- 2) documented dementia, aphasia, and psychosis
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 |
|---|---|---|
| The Diabetes Treatment Satisfaction QuestionnaireA six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied. | Behavioural | Telemedicine CBOC |
| Diabetes Empowerment ScaleA twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree. | Behavioural | Telemedicine CBOC |
| CBOC's undergo half-day joint-clinics via teleconferenceA patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park. | Behavioural | Telemedicine CBOC |
Primary outcome
A1c
Time frame: baseline and 18 months
Hemoglobin A1c is a measure of glycemic control
1 secondary outcome
Patient Satisfaction
Time frame: Base line and at18 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19468006Tomolo AM, Lawrence RH, Aron DC. A case study of translating ACGME practice-based learning and improvement requirements into reality: systems quality improvement projects as the key component to a comprehensive curriculum. Qual Saf Health Care. 2009 Jun;18(3):217-24. doi: 10.1136/qshc.2007.024729.
- Results publication: PubMed 20501929Pogach L, Aron D. Balancing hypoglycemia and glycemic control: a public health approach for insulin safety. JAMA. 2010 May 26;303(20):2076-7. doi: 10.1001/jama.2010.655. No abstract available.
- Results publication: PubMed 19885172F O Kern E, Beischel S, Stalnaker R, Aron DC, Kirsh SR, Watts SA. Building a diabetes registry from the Veterans Health Administration's computerized patient record system. J Diabetes Sci Technol. 2008 Jan;2(1):7-14. doi: 10.1177/193229680800200103.
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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.
David C Aron, MD MS principal investigator
Louis Stokes VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Diabetes Treatment Satisfaction Questionnaire, Diabetes Empowerment Scale and CBOC's undergo half-day joint-clinics via teleconference in people with Diabetes Mellitus Type 2 and Diabetes Mellitus, Type 1, run by US Department of Veterans Affairs at 2 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 5 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 15 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 12 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
A1c (time frame: baseline and 18 months). 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 NCT00119041, which also lists 3 linked publications.
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 15 Jun 2015; AzTrials last refreshed its copy on 6 Nov 2026.