Clinical trial NCT01075997: The Impact of a Video Cell Phone Reminder System on Glycemic Control in Patients With Diabetes Mellitus
Official title: The Impact of a Video Cell Phone Reminder System on Glycemic Control in Patients With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Lead sponsor: Walter Reed Army Medical Center
Sponsor class: FED
Collaborators: name: Affinity Networks, Inc.
First posted: 2010-02-25
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to determine whether having a video cell phone that gives daily reminders over a 6-month period to check blood surgery and take your diabetes medications can improve your diabetes control during that time and if that benefit lasts for up to 1 year.

Detailed description: The purpose of this study is to determine if a cell phone video reminder system will improve compliance and glycemic control in patients with diabetes mellitus when compared with standard of care. We plan to partner with Affinity Network, Inc., a local minority-owned small business, to provide broadband-enabled cell phone service to patients with diabetes mellitus. Their IntelaCare™ system will host the content and transmit it to the phones on a personalized schedule. This will be a prospective, randomized, controlled trial comparing patients with diabetes mellitus who receive daily video reminders via cell phone to take their medications and check their blood glucose with patients who are just given a cell phone without daily reminders. The primary endpoint will be improvement of glycemic control as measured by glycosylated hemoglobin (A1c). The secondary endpoints will compare mean daily glucose levels, the number of both hypoglycemic and hyperglycemic events, the amount of time spent in target blood glucose, and the perceived level of diabetes-related stress between the two groups. Patients in both groups will receive a broad-band enabled cell phone and cell phone service for the duration of the study. Patients will be randomized into a "cell phone" group (group A) and a "cell phone plus reminder" group (group B). They will be seen by their provider at least quarterly (or more often as clinically appropriate). Blood glucose readings will be downloaded from patients' glucometers at every provider visit (at least quarterly). Group B will receive a daily 15-second video from their provider reminding them to take their medication and to test their blood sugar and an educational "tip-of-the day." These reminders will be personalized and recorded by their provider. During the second 6 months, the patients will be followed by their provider at least quarterly. Improvement in glycemic control will be determined by quarterly measurements of A1c and the mean and standard deviation of blood glucose. In addition, the number of home blood glucose tests performed on a weekly basis will be compared. Compliance with medication will be determined by pharmacy refill records and pill counts. Quality-of-life will be measures using 2 validated instruments at 0, 26 and 52 weeks - the Problem Areas in Diabetes (PAID), which is a diabetes-related quality of life questionnaire and the SF-8, which is a general quality of life questionnaire for people with chronic disease.

Eligibility criteria: Inclusion Criteria:

* age 18 or greater
* A1c greater than 8%
* ability to use a cell phone and glucose meter
* ability to understand English
* on oral therapy and/or insulin

Exclusion Criteria:

* under age 18
* non-English speaking
* females who are pregnant, lactating, planning to become pregnant, or without a safe contraceptive method
* A1c less than 8%
* use of glucocorticoids, amphetamines, anabolic, or weight-reducing agents during the course of the study

Primary outcomes:
measure: The primary endpoint will be improvement of glycemic control as measured by glycosylated hemoglobin (A1c).
timeFrame: week 0, week 12, week 26, week 38, week 52
Secondary outcomes:
measure: To compare mean blood glucose levels,the number of hypo- and hyperglycemic events,the duration of time spent in target blood glucose range,the perceived level of diabetes-related stress and the perceived effect of diabetes on quality of life.
timeFrame: week 0, week 12, week 26, week 38, week 52
Other outcomes:
Locations:
city: Washington DC
country: United States
facility: Walter Reed Army Hospital Center
state: District of Columbia
Study officials:
affiliation: WRAMC
name: Amanda Bell, MD
role: PRINCIPAL_INVESTIGATOR
References: