DiabetesNCT00194805
Telehealth for Diabetes Self-Management
A study testing Telehealth for Diabetes Self Management in people with Diabetes and Aging, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- What is being tested?
- Telehealth for Diabetes Self Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Aug 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- 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.
- 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 (HDL:LDL ratio) will be measured to evaluate improvement in short-and-long term (3 months to one year) management of diabetes.
- Participants selected to participate in the computer/Internet 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.
- Maintaining a daily personal log of diabetes self care activities (blood sugar readings, diet, exercise, feet inspections, etc.)
- 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 site's 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.).
- Being tested
- Telehealth for Diabetes Self Management
- Keywords
- Internet, Diabetes, Education, Social Support
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth for Diabetes Self ManagementBehavioural
Telehealth for Diabetes Self ManagementOther
Web based education format delivered for a six month period
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subjects randomized into the treatment group received the computer treatment Receives: Behavioral: Telehealth for Diabetes Self Management; Other: Telehealth for Diabetes Self Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycosylated hemoglobin (A1C) levels.
Measured: 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.
Measured: 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startSep 2003
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Gail E Bond, Ph.D, Principal investigator, University of WashingtonFredric Wolf, Ph.D, Study chair, University of WashingtonMartha Price, DNs, Study director, University of WashingtonLinda Teri, PhD, Study chair, University of WashingtonJerry Palmer, Study chair, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194805
- Sponsor's protocol ID
- 03-5886-V03
- Other IDs
- 1K01NR008506-03
- Status last verified
- Nov 2007
- First submitted
- 15 Sep 2005
- Last updated
- 14 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth for Diabetes Self-Management
- ClinicalTrials.gov ID
- NCT00194805
- Acronym / sponsor ID
- 03-5886-V03
- Keywords
- Internet, Diabetes, Education, Social Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Sep 2003
- Study completion
- Aug 2007 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
- 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 (HDL:LDL ratio) will be measured to evaluate improvement in short-and-long term (3 months to one year) management of diabetes.
- Participants selected to participate in the computer/Internet 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.
- Maintaining a daily personal log of diabetes self care activities (blood sugar readings, diet, exercise, feet inspections, etc.)
- 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 site's 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Telehealth for Diabetes Self Management, Other: Telehealth for Diabetes Self ManagementSubjects randomized into the treatment group received the computer treatment |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth for Diabetes Self Management | Behavioural | 1 |
| Telehealth for Diabetes Self ManagementWeb based education format delivered for a six month period | Other | 1 |
Primary outcome
glycosylated hemoglobin (A1C) levels.
Time frame: one year
2 secondary outcomes
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.
Time frame: 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.
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2007.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail E Bond, Ph.D principal investigator
University of Washington
Fredric Wolf, Ph.D study chair
University of Washington
Martha Price, DNs study director
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth for Diabetes Self Management in people with Diabetes and Aging, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycosylated hemoglobin (A1C) levels. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2007.