Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194805
Status:
COMPLETED
Last Update Posted:
2007-11-14
First Post:
2005-09-15
Brief Title:
Telehealth for Diabetes Self-Management
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Telehealth for Diabetes Self-Management
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 participants 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
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 participants 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
Detailed Description:
This one year study plans to enroll 62 individuals into two groups One group will receive the standard diabetic care provided and the second group will receive the standard diabetic care and training on how to use a computer to access the Internet Participant assignment into either group is random like flipping a coin Study procedures will include the completion of questionnaires a blood pressure reading weight and a finger prick to obtain a blood sample
There will be a total of three visits One visit will occur before the study starts and at a six-month interval during the study period The time to complete the study procedures by the research staff is approximately 1 to 1½ hours
1 Questionnaires Participants will meet with a research staff person who will ask questions about dietary intake exercise activity blood glucose levels feet inspections past and current Internet activity and psychosocial well-being depression quality of life self-efficacy social support readiness to change and adjustment to diabetes The time estimated for completion is about 45 to 60 minutes
2 Physiologic Measures Participants will have their blood pressures taken weight measured using a scale and asked to provide 4-5 drops of blood from the fingertip to measure glycosylated hemoglobin HbA1c Cholesterol HDLLDL ratio will be measured to evaluate improvement in short-and-long term 3 months to one year management of diabetes
3 Participants selected to participate in the computerInternet study group will be contacted by research staff within one month to schedule a time to set-up the study computer equipment and receive computer training Three 2 hour sessions of computer training over a three-week period in participants homes will be scheduled Participants will also be expected to participate in following Internet study procedures available via the Internet from their homes
1 Maintaining a daily personal log of diabetes self care activities blood sugar readings diet exercise feet inspections etc
2 Participating in nurse led peer support question and answer chat sessions twice a month
d Read and respond to e-mail sent from the study nurse e Read health information on diabetes management depression and psychosocial well being that will be provided by the study nurse
Computer Training Training will be provided on how to use the computer access the study web page resources and participate in the nurse-led peer support group conference forum use e-mail and how to prepare and send a daily log of self-management activities blood sugar monitoring diet feet inspections and exercise Training will also be provided on how to use the study web sites bulletin board and the electronic prompt to verify completion of the weekly health reading assignment and how to develop and post an action plan on-line
The amount of time for the above Internet activities will vary depending on participants degree of interest in accessing the Internet resources provided Approximately 1-4 hours per week or more will be needed to complete the Internet activities Participants who are assigned to the intervention group who fail to respond to e-mail or to use any of the intervention resources for a one-week period will be contacted by telephone to determine the reason for not participating in the study activity technical knowledge deficit medical lack of ability lack of interest etc
There will be a total of three visits One visit will occur before the study starts and at a six-month interval during the study period The time to complete the study procedures by the research staff is approximately 1 to 1½ hours
1 Questionnaires Participants will meet with a research staff person who will ask questions about dietary intake exercise activity blood glucose levels feet inspections past and current Internet activity and psychosocial well-being depression quality of life self-efficacy social support readiness to change and adjustment to diabetes The time estimated for completion is about 45 to 60 minutes
2 Physiologic Measures Participants will have their blood pressures taken weight measured using a scale and asked to provide 4-5 drops of blood from the fingertip to measure glycosylated hemoglobin HbA1c Cholesterol HDLLDL ratio will be measured to evaluate improvement in short-and-long term 3 months to one year management of diabetes
3 Participants selected to participate in the computerInternet study group will be contacted by research staff within one month to schedule a time to set-up the study computer equipment and receive computer training Three 2 hour sessions of computer training over a three-week period in participants homes will be scheduled Participants will also be expected to participate in following Internet study procedures available via the Internet from their homes
1 Maintaining a daily personal log of diabetes self care activities blood sugar readings diet exercise feet inspections etc
2 Participating in nurse led peer support question and answer chat sessions twice a month
d Read and respond to e-mail sent from the study nurse e Read health information on diabetes management depression and psychosocial well being that will be provided by the study nurse
Computer Training Training will be provided on how to use the computer access the study web page resources and participate in the nurse-led peer support group conference forum use e-mail and how to prepare and send a daily log of self-management activities blood sugar monitoring diet feet inspections and exercise Training will also be provided on how to use the study web sites bulletin board and the electronic prompt to verify completion of the weekly health reading assignment and how to develop and post an action plan on-line
The amount of time for the above Internet activities will vary depending on participants degree of interest in accessing the Internet resources provided Approximately 1-4 hours per week or more will be needed to complete the Internet activities Participants who are assigned to the intervention group who fail to respond to e-mail or to use any of the intervention resources for a one-week period will be contacted by telephone to determine the reason for not participating in the study activity technical knowledge deficit medical lack of ability lack of interest etc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K01NR008506-03 | NIH | None | httpsreporternihgovquickSearch1K01NR008506-03 |