Trial Outcomes & Findings for Diabetes Telemedicine Consultation: A Systems Improvement Intervention (NCT NCT00119041)
NCT ID: NCT00119041
Last Updated: 2015-06-15
Results Overview
Hemoglobin A1c is a measure of glycemic control
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
304 participants
Primary outcome timeframe
baseline and 18 months
Results posted on
2015-06-15
Participant Flow
Participant milestones
| Measure |
Telemedicine CBOC
Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.
The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.
Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.
CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park.
|
Control CBOC
The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
|
Provider Interview
Qualitative interviews with providers
|
|---|---|---|---|
|
Overall Study
STARTED
|
199
|
83
|
22
|
|
Overall Study
COMPLETED
|
199
|
83
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Diabetes Telemedicine Consultation: A Systems Improvement Intervention
Baseline characteristics by cohort
| Measure |
Telemedicine CBOC
n=199 Participants
Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.
The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.
Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.
CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park.
We did not collect gender and age related data.
|
Control CBOC
n=83 Participants
The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
|
Provider Interview
n=22 Participants
Qualitative interviews with providers
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18 years and older
|
199 participants
n=93 Participants
|
83 participants
n=4 Participants
|
22 participants
n=27 Participants
|
304 participants
n=483 Participants
|
|
Sex/Gender, Customized
|
NA participants
n=93 Participants
|
NA participants
n=4 Participants
|
NA participants
n=27 Participants
|
NA participants
n=483 Participants
|
PRIMARY outcome
Timeframe: baseline and 18 monthsHemoglobin A1c is a measure of glycemic control
Outcome measures
| Measure |
Telemedicine CBOC
n=199 Participants
Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.
The Behavioral: The Diabetes Treatment Satisfaction Questionnaire given during this phase along with the Behavioral: Diabetes Empowerment Scale and the Behavioral: CBOC's undergo half-day joint-clinics via teleconference.
The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.
Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.
CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park.
|
Control CBOC
n=83 Participants
Received the questionnaires by mail and had no intervention of diabetes teleconference
|
|---|---|---|
|
A1c
baseline
|
10.1 percentage of Hb that is glycosylated
Interval 6.4 to 14.9
|
9.32 percentage of Hb that is glycosylated
Interval 5.3 to 15.9
|
|
A1c
18 months
|
8.82 percentage of Hb that is glycosylated
Interval 5.0 to 14.0
|
8.36 percentage of Hb that is glycosylated
Interval 6.0 to 13.0
|
SECONDARY outcome
Timeframe: Base line and at18 months.Population: The number subjects was determined on the size of the CBOC.
Diabetes Treatment Satisfaction Questionnaire (DTSQ) consists of 6 questions and ranges from 0-6. The following aspects of current treatment included were convenience, flexibility, understanding and continuing present form of treatment. The total range of the DTSQ is the sum of the 6 individual questions scores (i.e. 0-36) Higher scores represent greater satisfaction/convenience.
Outcome measures
| Measure |
Telemedicine CBOC
n=199 Participants
Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.
The Behavioral: The Diabetes Treatment Satisfaction Questionnaire given during this phase along with the Behavioral: Diabetes Empowerment Scale and the Behavioral: CBOC's undergo half-day joint-clinics via teleconference.
The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.
Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.
CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park.
|
Control CBOC
n=83 Participants
Received the questionnaires by mail and had no intervention of diabetes teleconference
|
|---|---|---|
|
Patient Satisfaction
baseline
|
24.33 units on a scale
Interval 0.0 to 36.0
|
23.29 units on a scale
Interval 6.0 to 36.0
|
|
Patient Satisfaction
18 months
|
23.55 units on a scale
Interval 8.0 to 36.0
|
23.9 units on a scale
Interval 8.0 to 36.0
|
Adverse Events
Telemedicine CBOC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control CBOC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Provider Interviews
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place