Improving Self Management Skills of Older Adults With Diabetes

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
Improving the Self Management Skills of Older Adults With Diabetes

Conditions
-----------------
Type 2 Diabetes, Diabetes

Intervention / Treatment
-----------------
* Behavioral: Diabetes Self Management Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes WellPoint insurance or medicare supplement plan participant 18 years or older Exclusion Criteria: Treatment for cancer in past year Pregnant Under 18 Previously taken a Stanford self-management program

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetes Self-Management Program<br>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. | Behavioral: Diabetes Self Management Program<br>* The interventions include modeling and action-planning to enhance self-efficacy.<br>* Other names: Better Choices Better Health--Diabetes;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic control HbA1C |  | Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom:fatigue | Single item visual numeric scale. Examined at baseline, 6 months and 12 months. Paired t-tests used to assess if change significant. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | baseline to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, patient education, self management, health improvement