Telehealth for Diabetes Self-Management

NCT00194805 | Completed DMC

• 2 other identifiers: 03-5886-V031K01NR008506-03
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the feasibility and short and-long-term efficacy of a web-based telehealth intervention with community-dwelling older adults who have been diagnosed with type 2 diabetes. Effectiveness will be evaluated using multiple measures within three different domains: 1) physical (glycosylated hemoglobin \[HbA1C\], weight, and lipid levels); 2) behavioral (monitoring blood glucose levels, feet inspections, diet, and exercise frequency), and 3) psychosocial (depression, quality of life, social support, and adjustment to diabetes). This is a randomized controlled trial of a web-based telehealth intervention designed to improve self-management behaviors in a group of community dwelling older diabetics. Two groups of participants will be recruited and randomized over a four-month period during years 01 and 02. Participants in the control group will receive standard diabetic care provided by their provider. Participants in the intervention group will receive computer training in the participant's home in how to access and utilize the web-based telehealth study webpage. The intervention will consist of a program designed and delivered via the Internet to improve the participants' diabetes self-management behaviors using behavioral and motivational strategies and cues to modify perceptions of self-efficacy and beliefs regarding the ability to affect the progress of the disease and change personal behavior.

Conditions

Diabetes; Aging

Keywords

Internet; Diabetes; Education; Social Support

Outcome Measures

Primary Outcomes (1)

• glycosylated hemoglobin (A1C) levels.

  one year

Secondary Outcomes (2)

• Study participants who receive the web-based telehealth intervention will have fewer depression symptoms and higher quality of life, social support, at post-test (short-term) than participants in the control group.

  1 year

• Study participants who receive the web-based telehealth intervention will have fewer depression symptoms and higher quality of life, social support, at the 12 month (long-term) follow-up than participants in the control group.

  one year

Study Arms (1)

1

EXPERIMENTAL

Subjects randomized into the treatment group received the computer treatment

Behavioral: Telehealth for Diabetes Self Management; Other: Telehealth for Diabetes Self Management

Interventions

Telehealth for Diabetes Self Management BEHAVIORAL

1

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with Type 2 diabetes (American Diabetes Association criteria), i.e., fasting blood sugar levels of 126 mg/d or non-fasting levels of 200 mg/d when not taking glycemic control medication for diabetes
• diagnosed with diabetes for at least one year
• living in a non-institutional home in the community
• age 60 or older
• willing to be randomized
• able to read and write English or have an available caregiver or family member who can provide the necessary language translation.

You may not qualify if:

• moderate to severe cognitive impairment (less than 24 on the Mini Mental State Examination)
• severe vision impairment (greater than or equal to 9 on the Functional Vision Screening Scale);
• impairment of Activities of Daily Living (greater than 2 on Katz's Activities of Daily Living Scale);
• inability to hold and move objects; push buttons or use a trackball or a telephone;
• the presence of terminal debilitating medical conditions likely to result in death or severe disability prior to completion of the study;
• severe expressive or receptive communication impairment (inability to communicate will interfere with the administration of outcome measures), or
• no available phone-line or free electrical outlet

Sponsors & Collaborators

• University of Washington: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Gail E Bond, Ph.D

  University of Washington

  PRINCIPAL INVESTIGATOR

• Fredric Wolf, Ph.D

  University of Washington

  STUDY CHAIR

• Martha Price, DNs

  University of Washington

  STUDY DIRECTOR

• Linda Teri, PhD

  University of Washington

  STUDY CHAIR

• Jerry Palmer

  University of Washington

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 19, 2005
• Study Start: September 1, 2003
• Study Completion: August 1, 2007
• Last Updated: November 14, 2007

Record last verified: 2007-11

Locations

US (1)