Type 2 DiabetesDONCMNCT01659294
Diabetes Outcomes and Nurse Case Manager Study
A study testing Nurse Case Management and standard diabetologist care in people with Type 2 Diabetes, run by BCDiabetes.Ca at 1 site in Canada.
Trial summary
This study will examine whether patients with diabetes who are either 1) newly discharged from hospital or 2) referred to an endocrinologist for management will have better diabetes outcomes when their care is managed primarily by a dedicated case manager (intervention) than by an endocrinologist (standard care) after… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Nurse Case Management and standard diabetologist care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2012to Feb 2015
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- A1c > 8.0 or
- BP > 140/90 or
- LDL cholesterol > 2.0 (72 mg/dl)
Who cannot join
- inability to speak English or to be assisted by somebody fluent in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Nurse Case Management on Diabetes-related Health Outcomes in a Specialty Care Setting: A Randomized Controlled Trial
This study will examine whether patients with diabetes who are either 1) newly discharged from hospital or 2) referred to an endocrinologist for management will have better diabetes outcomes when their care is managed primarily by a dedicated case manager (intervention) than by an endocrinologist (standard care) after 6 months of treatment.
Read the detailed description
The study will be a randomized-control trial recruiting patients with type 2 diabetes in a specialty care setting from two sources:
- referred by family physicians with inadequate glycemic control likely requiring exogenous insulin therapy
- referred by medical staff at Vancouver General Hospital or St. Paul's Hospital during in-patient care \& about to be discharged (Appendix 1).
Patients who meet the inclusion criteria will be randomly assigned into either the NCM group or SC group.
- Conditions
- Type 2 Diabetes
- Being tested
- Nurse Case Management, standard diabetologist care
- Keywords
- Type 2 diabetes, outcomes, case management
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse Case ManagementBehavioural
standard diabetologist careBehavioural
routine care by diabetologist \& team
| Study group | Role | What they receive |
|---|---|---|
| nurse case management | Experimental | nurse case management of diabetic variables Receives: Behavioral: Nurse Case Management |
| standard diabetologist care | Active comparator | standard diabetologist care Receives: Behavioral: standard diabetologist care |
What is being measured
The primary outcome is the main question the study is designed to answer.
A1c
changes in A1C between NCM vs. SC
Measured: 6 months
diabetes distress (DDS)
changes in diabetes distress between NCM vs. SC. Diabetes Distress (DDS) will be assessed using the 17-item Diabetes Distress Scale (DDS) developed by Polonsky and colleagues. The DDS measures emotional distress and functioning as it relates to living with diabetes. Responses are scored on a 6-point Likert scale (1=no problem to 6=serious problem). A total score is derived by taking the mean of all items. A score of < 2 indicate low/no distress, 2 - 2.9 indicates moderate distress, and score of ≥ 3 indicates high distress.
Measured: 6 months
Secondary outcomes (7)
blood pressure
changes in BP between NCM vs. SC. Blood pressure will be measured using an Omron Digital Blood Pressure Monitor HEM-907. Two upper arm readings are taken with the average of the two recorded.
Measured: 6 months
BMI
changes in BMI between NCM vs. SC. Height and weight will be measured using the Healthometer mechanical eye level upright standard physician scale with attached stadiometer. Body mass index (BMI) are calculated as weight in kilograms divided by height in meters squared.
Measured: 6 months
Self-management behaviours
changes in behaviour habits between NCM vs. SC. Self-management behaviours will be assessed using items from the Summary of Diabetes Self-Care Activities Measure-revised (SDSCA-R).This instrument measures self-care behaviors including diet, exercise, blood sugar testing and foot care. Participants are asked to report the number of days in the past week (range 0-7 days) in which he/she performed specific self-care practices. Greater number of days indicates better self-management.
Measured: 6 months
Medication adherence
changes in medication adherence between NCM vs. SC. Medication adherence will be assessed using the 4-item Moriskyscale that assesses beliefs and behaviors associated with taking medications.Responses are scored on a dichotomous scale: 0=no and 1=yes. A total score is calculated by adding up all items with lower scored indicating better adherence.
Measured: 6 months
Patient motivation
change in patient motivation between NCM vs. SC. motivation will be measured by the 13-item Patient Activation Measure which assesses participants' self-reported knowledge, skills, and confidence an individual has when managing his/her own health.
Measured: 6 months
Diabetes-specific Social Support
change in diabetes-specific social support between NCM vs. SC Diabetes-specific Social Support will be assessed with a 4-item scale developed by Tang et al. that measures amount of support and satisfaction with support from family, friends and the health care team.
Measured: 6 months
Depressive Symptoms Severity
change in depressive symptoms between NCM vs. SC Depressive Symptom Severity will be assessed using the 9-item PRIME-MD Patient Health Questionnaire (PHQ-9)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- BCDiabetes.Ca
- Sponsor type
- Research network
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Tom Elliott, BCDiabetes.Ca
- Investigators
- Tom Elliott, MBBS, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659294
- Sponsor's protocol ID
- 1-Elliott
- Acronym
- DONCM
- Status last verified
- Jan 2016
- First submitted
- 2 Aug 2012
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nurse Case Management on Diabetes-related Health Outcomes in a Specialty Care Setting: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01659294
- Acronym / sponsor ID
- DONCM / 1-Elliott
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, outcomes, case management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- BCDiabetes.CaResearch network
- Collaborators
- Sanofi
- Study start
- Aug 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 7 Aug 2012 (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.
This study will examine whether patients with diabetes who are either 1) newly discharged from hospital or 2) referred to an endocrinologist for management will have better diabetes outcomes when their care is managed primarily by a dedicated case manager (intervention) than by an endocrinologist (standard care) after 6 months of treatment.
Detailed description
The study will be a randomized-control trial recruiting patients with type 2 diabetes in a specialty care setting from two sources:
- referred by family physicians with inadequate glycemic control likely requiring exogenous insulin therapy
- referred by medical staff at Vancouver General Hospital or St. Paul's Hospital during in-patient care \& about to be discharged (Appendix 1).
Patients who meet the inclusion criteria will be randomly assigned into either the NCM group or SC group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nurse case management | Experimental | Behavioral: Nurse Case Managementnurse case management of diabetic variables |
| standard diabetologist care | Active comparator | Behavioral: standard diabetologist carestandard diabetologist care |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes
- A1c > 8.0 or
- BP > 140/90 or
- LDL cholesterol > 2.0 (72 mg/dl)
Key exclusion criteria (1 listed)
- inability to speak English or to be assisted by somebody fluent in English
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 |
|---|---|---|
| Nurse Case Management | Behavioural | nurse case management |
| standard diabetologist careroutine care by diabetologist \& team | Behavioural | standard diabetologist care |
Primary outcome
A1c
Time frame: 6 months
changes in A1C between NCM vs. SC
diabetes distress (DDS)
Time frame: 6 months
changes in diabetes distress between NCM vs. SC. Diabetes Distress (DDS) will be assessed using the 17-item Diabetes Distress Scale (DDS) developed by Polonsky and colleagues. The DDS measures emotional distress and functioning as it relates to living with diabetes. Responses are scored on a 6-point Likert scale (1=no problem to 6=serious problem). A total score is derived by taking the mean of all items. A score of < 2 indicate low/no distress, 2 - 2.9 indicates moderate distress, and score of ≥ 3 indicates high distress.
7 secondary outcomes
blood pressure
Time frame: 6 months
BMI
Time frame: 6 months
Self-management behaviours
Time frame: 6 months
Medication adherence
Time frame: 6 months
Patient motivation
Time frame: 6 months
Diabetes-specific Social Support
Time frame: 6 months
Depressive Symptoms Severity
Time frame: 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 27 Jan 2016.
- ProtocolLink provided by the sponsor.
- Consent formLink provided by the sponsor.
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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.
Tom Elliott, MBBS principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse Case Management and standard diabetologist care in people with Type 2 Diabetes, run by BCDiabetes.Ca at 1 site in Canada.
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 4 inclusion and 1 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 27 Jan 2016. 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 Canada. 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?
A1c (time frame: 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 27 Jan 2016.