# Presentation: 218804

## Improving Diabetes Self-Care with a PDA

**Improving Diabetes Self-Care with a PDA**

**Samuel N. Forjuoh, M.D., M.P.H., Dr.P.H.**
- Professor & Director of Research
- Department of Family & Community Medicine
- Texas A&M College of Medicine
- Scott & White, Temple, TX
**AHRQ National PBRN Research Conference, Bethesda, MD, May 17, 2007**

## Background

- As a chronic disease, diabetes management requires active patient involvement
- Use of home glucose monitors in the 1980s changed diabetes monitoring
- Growing interest in the impact of emerging HIT (e-Health) on patient outcomes
- Recent attention on the role of electronic diaries in achieving better diabetes self-care
- PDA use in diabetes self-care activity monitoring is understudied

## Major Research Questions

- Are patients with type 2 diabetes (T2DM) willing to adopt the use of the PDA to assist with their self-care activity monitoring?
- Will the PDA use improve patients’ glycemic control (i.e., reduce their HbA1c levels)?

## Study Objectives

**Study Objectives**

- Document initial experiences in testing PDA use for diabetes self-care activity monitoring
- Highlight some major research challenges
- Identify individuals most likely to adopt this technology
- Explore whether PDA use will lead to improved glycemic control
- Examine whether improvement in glycemic control will vary by PDA usage

## Study Design & Setting

- Study design
- Pretest/posttest intervention study
- Study setting
- Four (4) primary care clinics of a large university-affiliated, multi-specialty group practice associated with an 186,000-member HMO in central Texas
- Killeen, Northside, Santa Fe, & Waco – all affiliated with CenTexNet
- Study period
- September 2005 – November 2006
- Human subject concerns
- Reviewed & approved by S&W IRB
- Written informed consent from participants

## Study Sites

**1**

**2**

**3**

**4**

## Study Subjects

- Inclusion criteria
- 18 years or older with type 2 diabetes (T2DM)
- Last measured HbA1c ≥8.0% (*at* research orientation visit)
- Ability to read, write & speak English
- Willingness & ability to attend 3 required research visits
- Exclusion criteria
- Documented alcoholism or drug abuse problem
- Vision or dexterity problems
- Pregnancy

## Subject Enrollment Process

- Mailing of recruitment letters
- Enlisted the participation of MDs at study sites
- Identified eligible patients via Data Warehouse (HbA1c ≥8.0%)
- Sent list of patients/inv. letter to each MD for signed approval
- Invited MD approved patients for study participation
- Interested patients asked to call a designated RA
- Phone screening of prospective subjects
- Reviewed inclusion/exclusion criteria
- Obtained oral permission to review medical records
- Scheduled research orientation visit
- Notified subject to cancel appt. if any exclusion identified
- Research orientation visit for eligible subjects
- Obtained written informed consent
- Checked HbA1c to confirm eligibility (HbA1c ≥8.0%)

## Intervention

- Loaned PDA
- Pre-installed “Diabetes Pilot” management software
- Password-protected, registered Tungsten E Palm Pilot
- One-on-one training in PDA & software use
- Instruction conducted by a trained RA
- Used a pictorial instructional manual developed by RA
- Involved hands-on training
- Used 1st month as a run-in to ensure proper use of PDA
- Monitoring phone call & support
- 1-week follow-up
- Trouble-shooting phone contact number

## PDA & ‘Diabetes Pilot’ Software Use Instruction Provided 

- General features & operations of PDA
- Turning device on & off
- Charging & care of the device
- Entering reminders/alarms
- Editing/deleting & “notes” feature
- Icons & navigating the software
- Correct data entry saving by tabbing <Done> & <OK>
- “Diabetes pilot” specific features & operations
- Blood sugar readings & graphing occasionally
- Type & duration of daily exercise
- Diet & carbohydrate counter
- Medication entry

## ‘Diabetes Pilot’ Program

## Study Activity & Data Measurement Matrix 

| ACTIVITY | PHONE SCREENING | ORIENTATION VISIT 1 | (3-MO) VISIT 2 | (6-MO) VISIT 3 |
| --- | --- | --- | --- | --- |
| Oral Consent | X |  |  |  |
| Medical Record Review | X |  |  |  |
| Schedule (orient.) Visit 1 | X |  |  |  |
| Written Consent |  | X |  |  |
| HbA1c Check |  | X |  | X |
| Ht |  | X |  |  |
| Questionnaires |  | X | X | X |
| BP & Wt |  | X | X | X |
| Stipend (Wal-Mart $20) |  | X | X | X |
| Monitor correct PDA use |  |  | X | X |
| Schedule (3-mo) Visit 2 |  | X |  |  |
| Schedule (6-mo) Visit 3 |  |  | X |  |
| Return PDA |  |  |  | X |

## Data Collection Tools

- Socio-demographic & PDA use survey [_**visit 1**__]_
- PDA use tracking survey [_**visits 2 & 3**__]_
- Diabetes self-care activity (DSCA) [_**visits 2 & 3**__]_
- Blood sugar testing
- Exercise (physical activity)
- Foot care
- Diet (nutritional intake)
- Health-related quality of life (HRQOL-4) [_**visits 2 & 3**__]_
- General health status
- Physical health
- Mental health
- Limitation days
- User feedback session (volunteer participants)

## Data Analysis

- Comparison of study participants
- Intervention completers vs. non-completers
- Descriptive, univariate analysis
- Means, medians, SE, SD, IQR
- Process data
- PDA use tracking between 3 & 6 months
- SDSCA measures coded into subscales between 3 & 6 months
- Outcome data
- HbA1c changes from baseline to 6 months
- Changes in other outcomes between 3 & 6 months
- Statistical analysis
- T-test, Chi-square text, Fisher’s exact test, or Wilcoxon test
- Trends by PDA usage patterns
- Low users (<3 in last 7 days) vs. High users (≥3)
- Significance level of *P* < .05

## Flow of Subject Recruitment and Follow-up

**Mailings sent out**
**(N=626)**

**Response to mailings**
**(N=98)**

**Not interested in study**
**(n=2)**

**Cancelled appointments**
**(n=7)**

**Met all study  inclusion criteria**
**(N=43)**

**Did not meet **
**inclusion criteria**
**(n=28)**

**Not contacted / target reached**
**(n=18)**

**Dropped out of study [33%]**
**(n=14)**

**3-months follow-up [58%]**
**(N=25)**

**Could not be reached [9%]**
**(n=4)**

**6-months follow-up [72%]**
**(N=18)**

**Dropped out of study [20%]**
**(n=5)**

**Could not be reached [8%]**
**(n=2)**

## Table 1Baseline Characteristics of Study Participants*

| 

Characteristic | Participants Completing the Intervention
(N=18) | Participants Not Completing the Intervention
(N=25) | 
P-value |
| --- | --- | --- | --- |
| Age, mean (SD), y
Male
White race
College grad/Grad school
Ann family income ≥$30,000
Have HMO insurance
Weight, mean (SD), kg
BMI, mean (SD) † | 57.6 (9.9)
44.4
55.6
38.9
72.2
70.6
97.4 (21.7)
35.4 (7.8) | 53.3 (10.1)
32.0
68.0
40.0
66.7
84.0
100.2 (24.1)
35.9 (7.2) | .17
.61
.41
.40
.16
.13
.70
.82 |
| * Data expressed as percentages unless otherwise specified
† Calculated as weight in kilogram divided by the square of height in meters
SD=Standard deviation; HMO=Health maintenance organization; BMI=Body mass index  |  |  |  |

## Table 1 (contd.)Baseline Characteristics of Study Participants*

| 

Characteristic | Participants Completing the Intervention
(N=18) | Participants Not Completing the Intervention
(N=25) | 
P-value |
| --- | --- | --- | --- |
| Ever used a computer
Have reg. access to a computer
Use e-mail
Use the Internet
Ever used a PDA
Own a PDA now | 100
88.2
83.3
88.9
22.2
11.1 | 84.0
87.5
84.0
84.0
16.0
8.0 | .13
1.00
1.00
1.00
.70
1.00 |
| * Data expressed as percentages unless otherwise specified |  |  |  |

## Table 2No. Days in Past 7 Days Specified PDA Feature Used to Assist with Self-Care Activity Monitoring

| 
Specific PDA Feature | 3-mo visit
Mean (SE) | 6-mo visit
Mean (SE) | 
Mean Diff (96% CI) |
| --- | --- | --- | --- |
| Keep track of appointments
Store phone numbers/addresses
Save memos/messages
Keep track of tasks w/ reminder
The calculator feature
Retrieve info on diabetes
Record blood sugar readings
Record type/duration of daily exercise
The carbohydrate counter
Enter medications
Use reminder feature to take med
Use reminder for other diabetes care | 2.3 (0.6)
0.5 (0.4)
0.4 (0.2)
2.2 (0.7)
0.4 (0.2)
2.7 (0.6)
4.3 (0.7)
2.4 (0.7)
2.7 (0.8)
3.9 (0.7)
2.9 (0.8)
1.9 (0.6) | 2.3 (0.7)
1.1 (0.5)
1.1 (0.5)
2.7 (0.7)
0.6 (0.3)
3.6 (0.7)
3.2 (0.8)
2.0 (0.5)
2.4 (0.8)
3.1 (0.8)
2.8 (0.8)
2.9 (0.8) | 0 (-1.2 to 1.2)
+0.6 (-0.6 to 1.8)
+0.7 (-0.5 to 1.9)
+0.5 (-1.2 to 2.3)
+0.2 (-0.6 to 1.0)
+0.9 (-0.1 to 1.9)
-1.1 (-2.9 to 0.6)
-0.4 (-1.6 to 0.7)
-0.3 (-0.7 to 0.1)
-0.8 (-2.6 to 1.1)
-0.1 (-1.7 to 1.5)
+1.0 (-0.1 to 2.1) |
| SE=Standard error; CI=Confidence intervals |  |  |  |

## Table 3 No. Days in Past 7 Days PDA Used to Assist with Selected Diabetes Self-Care Activity Monitoring

| 
SDSCA Subscale | 3-mo visit
Mean (SE) | 6-mo visit
Mean (SE) | Mean Diff (96% CI)
% Change (95% CI) |
| --- | --- | --- | --- |
| Blood sugar testing

Exercise

Foot care

General diet | 4.9 (0.6)

3.7 (0.5)

4.1 (0.4)

3.9 (0.4) | 5.8 (0.4)

3.5 (0.5)

5.2 (0.3)

4.4 (0.4) | +0.9 (-0.5 to 2.3)
+17.9 (-9.8 to 45.5)
-0.2 (-0.6 to 1.1)
-6.7 (-29.1 to 15.6)
+1.1 (0.4 to 1.7)
+25.6 (10.6 to 40.5)
+0.5 (0.0 to 1.1)
+13.6 (0.1 to 27.1) |
| SDSCA=Summary of Diabetes Self-Care Activities measure
SE=Standard error; CI=Confidence intervals |  |  |  |

## Table 3 (contd.) No. Days in Past 7 Days PDA Used to Assist with Selected Diabetes Self-Care Activity Monitoring

| 
SDSCA Subscale | 3-mo visit
Mean (SE) | 6-mo visit
Mean (SE) | Mean Diff (96% CI)
% Change (95% CI) |
| --- | --- | --- | --- |
| Space carbohydrates

Eat 5+ fruits/veggie

Eat high-fat foods

Eat packaged foods | 4.5 (0.6)

4.0 (0.6)

3.3 (0.4)

5.1 (0.5) | 4.4 (0.6)

4.2 (0.6)

3.6 (0.3)

4.9 (0.4) | -0.1 (-0.9 to 0.7)
-1.5 (-18.9 to 16.1)
+0.2 (-1.0 to 1.3)
+4.5 (-23.8 to 32.5)
+0.3 (-0.4 to 0.9)
+8.5 (-11.0 to 27.7)
-0.2 (-1.0 to 0.6)
-3.5 (-19.7 to 12.9) |
| SDSCA=Summary of Diabetes Self-Care Activities measure
SE=Standard error; CI=Confidence intervals |  |  |  |

## Table 4Changes in HbA1c Levels and Other Outcome Variables

| 
Outcome | Baseline |  | 6-month Visit |  | Mean Difference
(95% CI) |
| --- | --- | --- | --- | --- | --- |
|  | Mean (SE) | Median
(IQR) | Mean (SE) | Median
(IQR) |  |
| HbA1c, %

SBP, mmHg

DBP, mmHg

Weight, kg

BMI, kg/m2 | 9.7 (0.3)

139.2 (4.4)

77.4 (2.0)

97.4 (5.1)

35.4 (1.8) | 9.4 
(8.6-10.5)
134.0
(123.5-150.0)
78.5
(70.0-82.0)
97.9
(75.5-116.5)
34.2
(28.8-40.1) | 8.0 (0.2)

154.2 (4.5)

79.8 (2.2)

97.2 (4.9)

35.3 (1.7) | 7.9 
(7.5-8.8)
148.5
(139.8-172.5)
81.0
(72.7-87.2)
95.4
(80.6-115.8)
34.2
(29.8-39.6) | -1.7
(-2.6 to -0.9)
+14.9
(0.9 to 29.0)
+2.4
(-2.8 to 7.7)
-0.2
(-2.1 to 1.7)
-0.1
(-0.8 to 0.7) |
| SBP=Systolic blood pressure; DSP=Diastolic blood pressure; BMI=Body mass index
SE=Standard error; IQR=Inter-quartile range; CI=Confidence intervals |  |  |  |  |  |

## Table 5Changes in Health-Related Quality of Life Measures

| 
HR-QOL  | 3-month Visit |  | 6-month Visit |  | P-value |
| --- | --- | --- | --- | --- | --- |
|  | n | % | n | % |  |
| GENERAL HEALTH STATUS
     Excellent
     Very Good
     Good
     Fair
     Poor | 
1
4
10
3
0 | 
5.6
22.2
55.6
16.7
- | 
2
5
7
4
0 | 
11.1
27.8
38.9
22.2
- | .56* |
| No limitation days from physical health (PH)† | 8 | 44.4 | 7 | 38.9 | .74 |
| No limitation days from mental health (MH) † | 12 | 66.7 | 7 | 38.9 | .10 |
| No limitation in ADL days from both PH/MH † | 13 | 72.2 | 8 | 44.4 | .09 |
| HR-QOL=Health-related quality of life measure; ADL=Activity of daily life
* Wilcoxon signed rank test; † During the past 30 days |  |  |  |  |  |

## Table 6Changes in HbA1c Levels and Other Outcome Variables by PDA Usage

| 
Outcome | Low PDA Users |  | High PDA Users |  |
| --- | --- | --- | --- | --- |
|  | Mean Difference | P-value | Mean Difference | P-value |
| HbA1c, % | -1.55 | .024 | -1.85 | .015 |
| SBP, mmHg | +23.22 | .070 | +6.67 | .37 |
| DBP, mmHg | +3.67 | .42 | +1.22 | .66 |
| BMI, kg/m2 | +0.01 | .98 | -0.19 | .76 |
| SBP=Systolic blood pressure; DSP=Diastolic blood pressure; BMI=Body mass index
ADL=Activity of daily life |  |  |  |  |

## Conclusions

- Incorporating PDA use in diabetes self-care activity monitoring by adults with T2DM resulted in significant reductions in HgA1c levels
- Initial increased blood sugar/medication monitoring
- Increased foot care/general diet monitoring
- Reductions were greater among high users of the PDA
- No significant change in reported health-related quality of life
- Improved patients’ ability to perform usual daily activities, i.e., feeling better about ability to handle disease

## Limitations

- Small sample size
- Most data were self-reported
- No baseline information on SDSCA & HR-QOL measures
- Intervention period may have been too short
- No true control group for comparison
- Study sites were conveniently selected & involved a single HMO making findings not generalizable to other settings

## Next Steps

- Replication
- Larger sample size
- More objective data especially from PDAs
- Obtain baseline data on the SDSCA measures & HR-QOL
- Longer intervention period
- Diverse settings in collaboration with other PBRNs
- Synchronize PDA data with care provided by PCPs

## Acknowledgments

- Funding Source
- The Texas A&M Health Services Research Program (HSRP)
- Research Team
- Marcia G. Ory, Ph.D., M.P.H.
- Michael D. Reis, M.D.
- Glen R. Couchman, M.D.
- Saundra Mason, B.S.N., R.N.
- Susan Molonket-Lanning
- Laura Gibson
- Other Support
- Sonia Holleman, CCRP (Dept of Research & Education)
- Ricky O’Banon, BBA (Dept of Research & Education)
- Mohammad H. Rajab, PhD, MPH (Dept of Biostatistics)
- Mike Biewenga, President, Digital Altitudes, LLC/ Diabetes Pilot

## Thank You for Your Attention & Feedback

**Thank You for Your Attention & Feedback**