Type 2 DiabetesNCT01943357
Improving Self Management Skills of Older Adults With Diabetes
A study testing Diabetes Self Management Program in people with Type 2 Diabetes and Diabetes, run by Stanford University at 1 site in United States.
Trial summary
The study will help determine if the Better Choices Better Health Diabetes program (community-based or online, also known as the Diabetes Self-Management Program) improves the hbA1C of people with Type-II diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Diabetes
- What is being tested?
- Diabetes Self Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Feb 2017
- 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
- type 2 diabetes
- WellPoint insurance or medicare supplement plan participant
- 18 years or older
Who cannot join
- Treatment for cancer in past year
- Pregnant
- Under 18
- Previously taken a Stanford self-management program
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94306
About this study
Official title: Improving the Self Management Skills of Older Adults With Diabetes
The study will help determine if the Better Choices Better Health Diabetes program (community-based or online, also known as the Diabetes Self-Management Program) improves the hbA1C of people with Type-II diabetes. The investigators will also examine 1) symptoms (fatigue, sleep, low blood sugar symptoms, depression, shortness of breath), 2) healthy behaviors (blood sugar monitoring; taking medications as prescribed; getting eye, foot, kidney and cholesterol exams; and activity), 3) the use of health care services. This project is a translational study to demonstrate the effectiveness of the intervention in the context of a major insurer.
Read the detailed description
Self-report questionnaires and hbA1c capillary blood collection kits will be administered at baseline (prior to the intervention), six-months and twelve-months. Differences between baseline and followup scores will be used to determine if participants have benefited from the intervention, using intent-to-treat methodology. Subgroups and delivery method (small-group or on-line) will be compared using repeated measures and analyses of covariance.
- Conditions
- Type 2 Diabetes, Diabetes
- Being tested
- Diabetes Self Management Program
- Keywords
- diabetes, patient education, self management, health improvement
- Medical subject headings
- 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.
Diabetes Self Management ProgramBehavioural
Also called Better Choices Better Health--Diabetes
The interventions include modeling and action-planning to enhance self-efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Self-Management Program | Experimental | Behavioral: Diabetes Self Management Program. Consists of either a six-week small-group face-to-face program with two peer leaders or an six-week peer-facilitated Internet-based program. Receives: Behavioral: Diabetes Self Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic control HbA1C
Measured: Baseline to 12 months
Secondary outcomes (10)
Symptom:fatigue
Single item visual numeric scale. Examined at baseline, 6 months and 12 months. Paired t-tests used to assess if change significant.
Measured: Baseline to 12 months
symptom: sleep
Single item visual numeric scale. Examined at baseline, 6 months and 12 months. Paired t-tests used to assess if change significant.
Measured: Baseline to 12 months
symptom: PHQ-8 depression
8-item scale. Examined at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant.
Measured: Baseline to 12 months
symptoms: hypoglycemic index
7-item scale. Examined at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant.
Measured: Baseline to 12 months
health behavior: blood glucose monitoring
Self report of how often monitor glucose at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant.
Measured: Baseline to 12 months
health behavior: medication adherence
3-item scale collected at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant.
Measured: baseline to 12 months
Health behavior: communication with physician
3-item scale collected at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant.
Measured: baseline to 12 months
health behavior: exercise
Minutes of exercise during last week self-reported at baseline, 6-months and 12-months. Paired t-tests used to assess if any changes are significant.
Measured: baseline to 12 months
health behavior/utilization: frequency of exams
Self report of how often examine feet and have eye, cholesterol and kidney levels tested. Collected at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant.
Measured: baseline to 12 months
Health care utilization
Physician, ED, hospital visits in last six-months. Self reported at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant.
Measured: baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2016
- Study completionFeb 2017
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.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- HealthCore, Inc.
- Responsible party
- Principal investigator, Kate Lorig, Stanford University
- Investigators
- Kate Lorig, DPH, Principal investigator, Stanford School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943357
- Sponsor's protocol ID
- 26679
- Other IDs
- 109554
- Status last verified
- Apr 2017
- First submitted
- 9 Sep 2013
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Self Management Skills of Older Adults With Diabetes
- ClinicalTrials.gov ID
- NCT01943357
- Acronym / sponsor ID
- 26679
- Conditions
- Type 2 Diabetes, Diabetes
- Keywords
- diabetes, patient education, self management, health improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- HealthCore, Inc.
- Study start
- Sep 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 16 Sep 2013 (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.
The study will help determine if the Better Choices Better Health Diabetes program (community-based or online, also known as the Diabetes Self-Management Program) improves the hbA1C of people with Type-II diabetes. The investigators will also examine 1) symptoms (fatigue, sleep, low blood sugar symptoms, depression, shortness of breath), 2) healthy behaviors (blood sugar monitoring; taking medications as prescribed; getting eye, foot, kidney and cholesterol exams; and activity), 3) the use of health care services. This project is a translational study to demonstrate the effectiveness of the intervention in the context of a major insurer.
Detailed description
Self-report questionnaires and hbA1c capillary blood collection kits will be administered at baseline (prior to the intervention), six-months and twelve-months. Differences between baseline and followup scores will be used to determine if participants have benefited from the intervention, using intent-to-treat methodology. Subgroups and delivery method (small-group or on-line) will be compared using repeated measures and analyses of covariance.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes Self-Management Program | Experimental | Behavioral: Diabetes Self Management ProgramBehavioral: Diabetes Self Management Program. Consists of either a six-week small-group face-to-face program with two peer leaders or an six-week peer-facilitated Internet-based program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- type 2 diabetes
- WellPoint insurance or medicare supplement plan participant
- 18 years or older
Key exclusion criteria (4 listed)
- Treatment for cancer in past year
- Pregnant
- Under 18
- Previously taken a Stanford self-management program
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 ProgramAlso: Better Choices Better Health--DiabetesThe interventions include modeling and action-planning to enhance self-efficacy. | Behavioural | Diabetes Self-Management Program |
Primary outcome
Metabolic control HbA1C
Time frame: Baseline to 12 months
10 secondary outcomes
Symptom:fatigue
Time frame: Baseline to 12 months
symptom: sleep
Time frame: Baseline to 12 months
symptom: PHQ-8 depression
Time frame: Baseline to 12 months
symptoms: hypoglycemic index
Time frame: Baseline to 12 months
health behavior: blood glucose monitoring
Time frame: Baseline to 12 months
health behavior: medication adherence
Time frame: baseline to 12 months
Health behavior: communication with physician
Time frame: baseline to 12 months
health behavior: exercise
Time frame: baseline to 12 months
health behavior/utilization: frequency of exams
Time frame: baseline to 12 months
Health care utilization
Time frame: baseline to 12 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 25 Apr 2017.
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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.
Kate Lorig, DPH principal investigator
Stanford School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Self Management Program in people with Type 2 Diabetes and Diabetes, run by Stanford 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 3 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 25 Apr 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 HbA1C (time frame: Baseline to 12 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 25 Apr 2017.