Trial Outcomes & Findings for Evaluation of Videoconferencing Versus Telephone Genetic Counseling (NCT NCT02108977)
NCT ID: NCT02108977
Last Updated: 2019-03-28
Results Overview
Subjects will be asked 8 True/False genetics-related questions before and after counseling to assess improvement and retention of genetic counseling knowledge and information
COMPLETED
NA
38 participants
Pre- and post- (within 2 weeks) genetic counseling
2019-03-28
Participant Flow
Participant milestones
| Measure |
Videoconferencing Genetic Consultation
Patients will travel to CBOC and receive genetic counseling session via videoconferencing
Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing
|
Teleconferencing Genetic Consultation
Patients will receive genetic counseling session via telephone (usual treatment)
Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
20
|
|
Overall Study
COMPLETED
|
8
|
19
|
|
Overall Study
NOT COMPLETED
|
10
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Videoconferencing Versus Telephone Genetic Counseling
Baseline characteristics by cohort
| Measure |
Videoconferencing Genetic Consultation
n=8 Participants
Patients will travel to CBOC and receive genetic counseling session via videoconferencing
Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing
|
Telephone Genetic Consultation
n=19 Participants
Patients will receive genetic counseling session via telephone (usual treatment)
Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
NA Not collected
n=99 Participants
|
NA Not collected
n=107 Participants
|
NA Not collected
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Pre- and post- (within 2 weeks) genetic counselingSubjects will be asked 8 True/False genetics-related questions before and after counseling to assess improvement and retention of genetic counseling knowledge and information
Outcome measures
| Measure |
Videoconferencing Genetic Consultation
n=8 Participants
Patients will travel to CBOC and receive genetic counseling session via videoconferencing
Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing
|
Teleconferencing Genetic Consultation
n=19 Participants
Patients will receive genetic counseling session via telephone (usual treatment)
Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)
|
|---|---|---|
|
Assessment of Knowledge Retention of Genetic Counseling Information Via 8-Question Pre- and Post-Counseling Assessment
Correct Answers Pre-Consultation
|
5.63 Number of correct answers (out of 8)
Standard Deviation 1.19
|
4.37 Number of correct answers (out of 8)
Standard Deviation 1.54
|
|
Assessment of Knowledge Retention of Genetic Counseling Information Via 8-Question Pre- and Post-Counseling Assessment
Correct Answers Post-Consultation
|
6.50 Number of correct answers (out of 8)
Standard Deviation 0.93
|
4.74 Number of correct answers (out of 8)
Standard Deviation 1.19
|
PRIMARY outcome
Timeframe: Within two weeks of receiving genetic counseling6-question Genetic Counseling Satisfaction Scale using 5-point Likert scale responses Strongly Disagree (1) to Strongly Agree (5)
Outcome measures
| Measure |
Videoconferencing Genetic Consultation
n=8 Participants
Patients will travel to CBOC and receive genetic counseling session via videoconferencing
Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing
|
Teleconferencing Genetic Consultation
n=19 Participants
Patients will receive genetic counseling session via telephone (usual treatment)
Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)
|
|---|---|---|
|
Satisfaction With Genetic Counseling Session Using the Genetic Counseling Satisfaction Scale
|
26.88 points on a scale of 30 (most satisfied)
Standard Deviation 3.04
|
25.21 points on a scale of 30 (most satisfied)
Standard Deviation 2.64
|
PRIMARY outcome
Timeframe: Within six weeks of receiving genetic counselingPopulation: A subsample of patients in each modality was interviewed to qualitatively assess the satisfaction with the counseling they received, and the benefits and limitations of the modality, whether it was by phone or video.
We asked the subjects to discuss specific aspects of each modality including the ease of use, navigation, and adaptability of each modality, conveying and comprehending genetic and numeric information, and perceived advantages and disadvantages of each modality.
Outcome measures
| Measure |
Videoconferencing Genetic Consultation
n=7 Participants
Patients will travel to CBOC and receive genetic counseling session via videoconferencing
Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing
|
Teleconferencing Genetic Consultation
n=6 Participants
Patients will receive genetic counseling session via telephone (usual treatment)
Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)
|
|---|---|---|
|
Qualitative Assessment of Genetic Counseling Experience, Barriers and Facilitators by PATIENTS
|
NA participants
The data is qualitative in nature collected via interview
|
NA participants
The data is qualitative in nature collected via interview
|
PRIMARY outcome
Timeframe: Within 4 weeks after study data collection was completedPopulation: A subsample of counselors in each modality was interviewed to qualitatively assess the satisfaction with the counseling they provided, and the benefits and limitations of the modality, whether it was by phone or video.
Five counselors agreed to be interviewed. We asked them to discuss specific aspects of each modality including the ease of use, navigation, and adaptability of each modality, conveying and comprehending genetic and numeric information, and perceived advantages and disadvantages of each modality.
Outcome measures
| Measure |
Videoconferencing Genetic Consultation
n=5 Participants
Patients will travel to CBOC and receive genetic counseling session via videoconferencing
Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing
|
Teleconferencing Genetic Consultation
n=5 Participants
Patients will receive genetic counseling session via telephone (usual treatment)
Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)
|
|---|---|---|
|
Qualitative Assessment of Genetic Counseling Experience, Barriers and Facilitators by GENETIC COUNSELORS
|
NA Participants
Data is qualitative in nature and collected via interview.
|
NA Participants
Data is qualitative in nature and collected via interview.
|
PRIMARY outcome
Timeframe: Cost analysis will be conducted in months 10-12 of grant period (projected January 1-March 31, 2015)Population: Travel distance data not applicable to the Teleconferencing group.
Labor (including training) and non-labor (e.g., equipment cost) inputs required to provide counseling via telephone versus videoconferencing. Patient travels costs will be included via self-report.
Outcome measures
| Measure |
Videoconferencing Genetic Consultation
n=8 Participants
Patients will travel to CBOC and receive genetic counseling session via videoconferencing
Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing
|
Teleconferencing Genetic Consultation
Patients will receive genetic counseling session via telephone (usual treatment)
Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)
|
|---|---|---|
|
Cost Analysis
|
67.29 Loss of Productivity Cost in US Dollars
Interval 44.78 to 97.88
|
—
|
Adverse Events
Videoconferencing Genetic Consultation
Teleconferencing Genetic Consultation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Santanu Datta, Health Sciences Research Specialist, HSR&D
Health Services Research & Development, Durham VAMC
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place