Article Figures & Data
Tables
Activity/Data Measurement Timing Phone Screening Orientation Visit (Visit 1) 3-Month Visit (Visit 2) 6-Month Visit (Visit 3) Obtain oral consent X Review medical record X Schedule (orientation) visit 1 X Obtain written informed consent X HbA1c check X X Height X Weight X X X Blood pressure X X X Sociodemographic/PDA use X PDA use tracking X X Diabetes self-care activity (DSCA) X X Health-related quality life (HRQOL-4) X X Loan PDA X Initial PDA use training X Monitor PDA use X X Schedule (3-month) visit 2 X Schedule (6-month) visit 3 X Stipend (Wal-Mart certificate for $20) X X X Return loaned PDA X Characteristic Eligible Subjects (N = 550) Participants* (N = 43) n (%) Nonparticipants (N = 507) n (%) P Value Age group (years) 0.99† <50 174 12 (29.3) 162 (32.0) 50 to 59 186 16 (39.0) 170 (33.5) ≥60 188 13 (31.7) 175 (34.5) Sex 0.09‡ Male 279 16 (37.2) 263 (51.9) Female 271 27 (62.8) 244 (48.1) Race/ethnicity 0.05† White (Non-Hispanic) 289 27 (62.8) 262 (51.7) Hispanic 101 9 (20.9) 92 (18.1) Black/African American 94 5 (11.6) 89 (17.6) Other 66 2 (4.7) 64 (12.6) Insurance type 0.03‡ HMO 484 33 (76.7) 451 (89.0) Other 66 10 (23.3) 56 (11.0) HbA1c (%)§ 0.03† <9.0 221 11 (25.6) 210 (41.4) 9.0 to 9.9 118 10 (23.3) 108 (21.3) ≥10 211 22 (51.1) 189 (37.3) * May not add to total due to missing data.
† χ2 test for linear trend.
‡ Yates corrected χ2 test.
§ Baseline HbA1c for participants and the most recent HbA1c in patient's record for nonparticipants.
Characteristic Number* % Age group (years) <50 12 29.3 50 to 59 16 39.0 ≥60 13 31.7 Sex Male 16 37.2 Female 27 62.8 Race/ethnicity White (non-Hispanic) 27 62.8 Hispanic 9 20.9 Black/African American 5 11.6 Other 2 4.7 Education Up to high school/GED 7 16.3 Some college 19 44.2 College degree/graduate degree 17 39.5 Annual family income <$30,000 13 31.0 $30,000 to $69,999 18 42.9 ≥$70,000 11 26.1 Insurance type HMO 33 76.7 Other 10 23.3 HbA1c (%) 8.0 to 8.9 12 27.9 9.0 to 9.9 14 32.6 10.0 to 10.9 8 18.6 ≥11.0 9 20.9 BMI 18.5 to 24.9 3 7.0 25.0 to 29.9 7 16.3 30.0 to 34.9 13 30.2 35.0 to 39.9 8 18.6 ≥40.0 12 27.9 * Numbers may not add to totals due to missing data and rounding.
Challenge Response Prior to subject enrollment 1. Selection of appropriate operating system (OS) Selected the Palm OS instead of the Windows OS due to ease of use and availability of more software programs 2. Selection of appropriate device Selected the Tungsten E instead of Zire 21 or Zire 31 due to its higher-resolution screen and its nonvolatile memory 3. Selection of appropriate software and vendor Selected the Diabetes Pilot software from Digital Altitudes due to prior collaboration, ease of use, and completeness 4. Teaching tool Developed a pictorial instructional manual in-house During subject enrollment 5. Low subject recruitment due to changes in HbA1c values between participant selection and orientation visit Revised HbA1c cutoff level from 9.0% to 8.0% 6. Low subject recruitment due to low response to mailed letters of recruitment Used more proactive strategies (eg, mounting a poster at each clinic) 7. Budgetary constraints due to having to provide pledged incentives to patient who fail to qualify at orientation visit Requested additional funds from department 8. Regulatory requirement of HbA1c testing that precludes testing in non-CLIA locations Negotiated with organizational authorities for CLIA certification at our preferred research location After subject enrollment 9. Loss of instructional manual by 2 participants Replaced lost manuals 10. Loss of data due to participant's failure to properly save entered data Retrained participants 11. Difficulties with data entry so choosing to enter all activities in a book Retrained participants 12. Participants’ frustration with daily dietary entry leading to their consideration to drop out of the study Informed participants that daily dietary entry is not required 13. Loss of PDA charger by 1 participant Replaced lost charger 14. Failure to return PDA after dropping out of study Made several calls to subject to return the PDA CLIA, Clinical Laboratory Improvement Amendments (of 1988).
