Type 1 DiabetesNATCHOSNCT00950963
Nurse Telephone Management of Cholesterol in Diabetes
A study testing Phone Counseling and Standard Clinical Care in people with Type 1 Diabetes and Type 2 Diabetes, run by Denver Health and Hospital Authority at 1 site in United States.
Trial summary
The current project is evaluating the effect of a nurse-administered phone care in diabetes to improve access to care and healthcare delivery. The setting is a federally qualified community health center serving over 1600 diabetic patients, 80% of whom are Latino. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- Phone Counseling and Standard Clinical Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 762 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jun 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients included in Denver Health diabetes registry.
- Type I and Type II diabetic patients
- Age >17 years old
- Actively utilizing Westside Clinic for their primary care (at least two visits in the past year)
- Speak either English or Spanish.
- Exclusion Criteria:We sought to maximize the generalizability of the study and therefore had only minimal exclusion criteria:
Show all 9Show fewer
- Pregnant or lactating women
- Patients with end-stage renal disease (creatinine > 3.0 mg/dl)
- Patients with a co-morbid illness with life expectancy less than 12 months, (e.g. terminal cancer or Child's Class C hepatic cirrhosis).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health, Westside Clinic
Denver, Colorado, 80204
About this study
Official title: Nurse-run, Telephone-based Intervention to Improve Lipids in Diabetics
The current project is evaluating the effect of a nurse-administered phone care in diabetes to improve access to care and healthcare delivery. The setting is a federally qualified community health center serving over 1600 diabetic patients, 80% of whom are Latino. Using our diabetes registry, we have randomly assigned 762 patients to either participate in a telephone-based, nurse-run outreach program (N=381) or to continue with usual care(N=381). Three of our registered nurses learned algorithms addressing management of cholesterol, blood pressure, kidney disease, aspirin use, eye screening, and pneumovax and influenza vaccines. The program began recruitment in September 2005 and has finished follow up in May 2007. The program initially focused only on cholesterol management utilizing national guidelines and algorithms on patients with elevated cholesterol (LDL) levels but has expanded to include glycemic and blood pressure control. We found that Registered Nurses were able and willing to provide telephone care to diabetic patients according to moderately complex algorithms and to track patient data electronically with overall job satisfaction. Overall, the nurses have expressed enthusiasm but have also experience frustrations with maintaining contact and improving motivation in patients. The impact of this program on diabetes outcomes and its cost-effectiveness is currently being analyzed with the goal of implementing this program in our institution.
Read the detailed description
This randomized, controlled trial tested the effectiveness of a nurse-run, telephone-based intervention to improve lipid control in patients with diabetes. Our patient population is predominantly low-income and Latino. Using our diabetes registry, we randomly assigned 381 patients to continue with their usual care and 381 to participate in our nurse run program. Three registered nurses learned algorithms for diabetes care. These algorithms address management of lipids, glycemic control, blood pressure, nephropathy, aspirin use, eye screening, pneumovax and influenza vaccines, obesity, and cigarette smoking. The nurses were also trained in motivational interviewing techniques and facilitation of patient self-management. The primary goal was to improve lipid control in our diabetic population. Secondary outcomes address blood pressure control, glycemic control, renal function, and medication adherence. In addition, a cost-effective analysis is being performed.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Being tested
- Phone Counseling, Standard Clinical Care
- Keywords
- Diabetes, Nurse phone intervention, lipid control
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone CounselingBehavioural
Also called Telephone Intervention, Counseling
Patient were contacted on a periodic basis via telephone to address there diabetes care.
Standard Clinical CareOther
Also called Standard Care
Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
| Study group | Role | What they receive |
|---|---|---|
| Phone Counseling | Experimental | The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact. Receives: Behavioral: Phone Counseling |
| Standard Care | Active comparator | Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses. Receives: Other: Standard Clinical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With a Low Density Lipid (LDL) Value Less Than 100 mg/dL
Number of patients with and without cardiovascular disease (CVD) with LDL value less than 100 mg/dL at the end of the study
Measured: 18 months
Secondary outcomes (3)
Number of CVD Patients With LDL Less Than 70 mg/dL.
Measured: 18 months
Number of Patients With BP Less Than 130/80 mm Hg
Number of patients meeting blood pressure goals as defined by the American Diabetes Association guidelines.
Measured: 18 months
Number of Patients With Hgb A1c Less Than 7 Percent at the End of the Study
Number of patients with Hgb A1c as recommended by the American Diabetes Association guidelines.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2009 (estimated)
- Study startSep 2005
- Primary completionMay 2007
- Study completionJun 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 (1)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 762 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Investigators
- Raymond O Estacio, MD, Principal investigator, Denver HealthHenry Fischer, MD, Study director, Denver Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950963
- Sponsor's protocol ID
- 05-509
- Acronym
- NATCHOS
- Status last verified
- Apr 2015
- First submitted
- 12 Jan 2009
- Last updated
- 28 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fischer H, Mackenzie T, McCullen K, Everhart R, Estacio RO. Design of a nurse-run, telephone-based intervention to improve lipids in diabetics. Contemp Clin Trials. 2008 Sep;29(5):809-16. doi: 10.1016/j.cct.2008.05.011. Epub 2008 Jun 11.
PubMed 18606250
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-run, Telephone-based Intervention to Improve Lipids in Diabetics
- ClinicalTrials.gov ID
- NCT00950963
- Acronym / sponsor ID
- NATCHOS / 05-509
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Keywords
- Diabetes, Nurse phone intervention, lipid control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 762 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Sep 2005
- Primary completion
- May 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 3 Aug 2009 (estimated)
- Results
- Posted 3 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current project is evaluating the effect of a nurse-administered phone care in diabetes to improve access to care and healthcare delivery. The setting is a federally qualified community health center serving over 1600 diabetic patients, 80% of whom are Latino. Using our diabetes registry, we have randomly assigned 762 patients to either participate in a telephone-based, nurse-run outreach program (N=381) or to continue with usual care(N=381). Three of our registered nurses learned algorithms addressing management of cholesterol, blood pressure, kidney disease, aspirin use, eye screening, and pneumovax and influenza vaccines. The program began recruitment in September 2005 and has finished follow up in May 2007. The program initially focused only on cholesterol management utilizing national guidelines and algorithms on patients with elevated cholesterol (LDL) levels but has expanded to include glycemic and blood pressure control. We found that Registered Nurses were able and willing to provide telephone care to diabetic patients according to moderately complex algorithms and to track patient data electronically with overall job satisfaction. Overall, the nurses have expressed enthusiasm but have also experience frustrations with maintaining contact and improving motivation in patients. The impact of this program on diabetes outcomes and its cost-effectiveness is currently being analyzed with the goal of implementing this program in our institution.
Detailed description
This randomized, controlled trial tested the effectiveness of a nurse-run, telephone-based intervention to improve lipid control in patients with diabetes. Our patient population is predominantly low-income and Latino. Using our diabetes registry, we randomly assigned 381 patients to continue with their usual care and 381 to participate in our nurse run program. Three registered nurses learned algorithms for diabetes care. These algorithms address management of lipids, glycemic control, blood pressure, nephropathy, aspirin use, eye screening, pneumovax and influenza vaccines, obesity, and cigarette smoking. The nurses were also trained in motivational interviewing techniques and facilitation of patient self-management. The primary goal was to improve lipid control in our diabetic population. Secondary outcomes address blood pressure control, glycemic control, renal function, and medication adherence. In addition, a cost-effective analysis is being performed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phone Counseling | Experimental | Behavioral: Phone CounselingThe telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact. |
| Standard Care | Active comparator | Other: Standard Clinical CarePatients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patients included in Denver Health diabetes registry.
- Type I and Type II diabetic patients
- Age >17 years old
- Actively utilizing Westside Clinic for their primary care (at least two visits in the past year)
- Speak either English or Spanish.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Phone CounselingAlso: Telephone Intervention, CounselingPatient were contacted on a periodic basis via telephone to address there diabetes care. | Behavioural | Phone Counseling |
| Standard Clinical CareAlso: Standard CarePatients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses. | Other | Standard Care |
Primary outcome
Number of Patients With a Low Density Lipid (LDL) Value Less Than 100 mg/dL
Time frame: 18 months
Number of patients with and without cardiovascular disease (CVD) with LDL value less than 100 mg/dL at the end of the study
3 secondary outcomes
Number of CVD Patients With LDL Less Than 70 mg/dL.
Time frame: 18 months
Number of Patients With BP Less Than 130/80 mm Hg
Time frame: 18 months
Number of Patients With Hgb A1c Less Than 7 Percent at the End of the Study
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18606250Fischer H, Mackenzie T, McCullen K, Everhart R, Estacio RO. Design of a nurse-run, telephone-based intervention to improve lipids in diabetics. Contemp Clin Trials. 2008 Sep;29(5):809-16. doi: 10.1016/j.cct.2008.05.011. Epub 2008 Jun 11.
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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.
Raymond O Estacio, MD principal investigator
Denver Health
Henry Fischer, MD study director
Denver Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone Counseling and Standard Clinical Care in people with Type 1 Diabetes and Type 2 Diabetes, run by Denver Health and Hospital Authority 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 9 inclusion and 0 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 28 Apr 2015. 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?
Yes. Results are posted in the registry (first posted 3 Aug 2009). 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?
Number of Patients With a Low Density Lipid (LDL) Value Less Than 100 mg/dL (time frame: 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 NCT00950963, 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 28 Apr 2015.