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The Impact of a Video Cell Phone Reminder System on Glycemic Control in Patients With Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Walter Reed Army Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Affinity Networks, Inc.
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT01075997
First received: February 24, 2010
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Device: cell phone delivered tele-educational
Device: cell phone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Impact of a Video Cell Phone Reminder System on Glycemic Control in Patients With Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:
  • The primary endpoint will be improvement of glycemic control as measured by glycosylated hemoglobin (A1c). [ Time Frame: week 0, week 12, week 26, week 38, week 52 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: week 0, week 12, week 26, week 38, week 52 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 170
Study Start Date: November 2007
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A cell phone tips
This group will receive a cell phone and cell phone service for 1 year. This group will receive a daily video reminders and tips for the first 6 months of the study. For the second 6 months this group will be seen by their providers at least every 3 months, but the video reminders and and tips will no longer be sent. The group will be instructed on how to use the cell phone. The group will be asked to check blood sugar on a schedule determined by their providers. The group will have blood sugars downloaded from from the glucometer by their providers at every visit and reviewed. The group will have the A1c measured. Also it will have this test repeated about every 3 months. They will continue to have monitored their A1c at 24, 38 and 52 weeks of the study.
Device: cell phone delivered tele-educational
This group will receive a cell phone and cell phone service for 1 year. This group will receive a daily video reminders and tips for the first 6 months of the study. For the second 6 months this group will be seen by their providers at least every 3 months, but the video reminders and and tips will no longer be sent. The group will be instructed on how to use the cell phone.
Other Name: A cell phone tips
Active Comparator: B no cell phone tips
This group will receive a cell phone and cell phone service for 1 year. For the second 6 months this group will be seen by their providers at least every 3 months. The group will be instructed on how to use the cell phone.The group will be asked to check blood sugar on a schedule determined by their provider. The groups will have blood sugars downloaded from from the glucometer by their provider at every visit and reviewed. The group will have A1c measured. Also it will have this test repeated about every 3 months. They will continue to have monitored their A1c at 24, 38 and 52 weeks of the study.
Device: cell phone
This group will receive a cell phone and cell phone service for 1 year. For the second 6 months this group will be seen by their providers at least every 3 months. The group will be instructed on how to use the cell phone.The group will be asked to check blood sugar on a schedule determined by your provider. The groups will have blood sugars downloaded from from the glucometer by your provider at every visit and reviewed.
Other Name: B no cell phone tips

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

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075997

Locations
United States, District of Columbia
Walter Reed Army Hospital Center
Washington DC, District of Columbia, United States, 20307
Sponsors and Collaborators
Walter Reed Army Medical Center
Affinity Networks, Inc.
Investigators
Principal Investigator: Amanda Bell, MD WRAMC
  More Information

No publications provided

Responsible Party: MAJ Amanda Bell MC,MD, Walter Reed Army Medical Center,
ClinicalTrials.gov Identifier: NCT01075997     History of Changes
Other Study ID Numbers: WU#07-13025
Study First Received: February 24, 2010
Last Updated: February 24, 2010
Health Authority: United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014