Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Videoconferencing Versus Telephone Genetic Counseling (EVTGC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02108977
Recruitment Status : Completed
First Posted : April 9, 2014
Results First Posted : April 21, 2016
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions Remote Consultation, Teleconsultation
Remote Consultation, Video
Interventions Other: Videoconferencing Genetic Consultation
Other: Teleconferencing Genetic Consultation
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Videoconferencing Genetic Consultation Teleconferencing Genetic Consultation
Hide Arm/Group Description

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

Patients will receive genetic counseling session via telephone (usual treatment)

Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)

Period Title: Overall Study
Started 18 20
Completed 8 19
Not Completed 10 1
Arm/Group Title Videoconferencing Genetic Consultation Telephone Genetic Consultation Total
Hide Arm/Group Description

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

Patients will receive genetic counseling session via telephone (usual treatment)

Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)

Total of all reporting groups
Overall Number of Baseline Participants 8 19 27
Hide Baseline Analysis Population Description
We define baseline participants as those who enrolled in the study and participated in the knowledge pre-test.
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Not collected
Number Analyzed 8 participants 19 participants 27 participants
NA [2]  NA [2]  NA [3] 
[1]
Measure Description: Age data was not collected
[2]
Age data was not collected
[3]
Total not calculated because data are not available (NA) in one or more arms.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 19 participants 27 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
8
 100.0%
19
 100.0%
27
 100.0%
1.Primary Outcome
Title Assessment of Knowledge Retention of Genetic Counseling Information Via 8-Question Pre- and Post-Counseling Assessment
Hide Description 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
Time Frame Pre- and post- (within 2 weeks) genetic counseling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Videoconferencing Genetic Consultation Teleconferencing Genetic Consultation
Hide Arm/Group Description:

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

Patients will receive genetic counseling session via telephone (usual treatment)

Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)

Overall Number of Participants Analyzed 8 19
Mean (Standard Deviation)
Unit of Measure: Number of correct answers (out of 8)
Correct Answers Pre-Consultation 5.63  (1.19) 4.37  (1.54)
Correct Answers Post-Consultation 6.50  (0.93) 4.74  (1.19)
2.Primary Outcome
Title Satisfaction With Genetic Counseling Session Using the Genetic Counseling Satisfaction Scale
Hide Description 6-question Genetic Counseling Satisfaction Scale using 5-point Likert scale responses Strongly Disagree (1) to Strongly Agree (5)
Time Frame Within two weeks of receiving genetic counseling
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Videoconferencing Genetic Consultation Teleconferencing Genetic Consultation
Hide Arm/Group Description:

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

Patients will receive genetic counseling session via telephone (usual treatment)

Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)

Overall Number of Participants Analyzed 8 19
Mean (Standard Deviation)
Unit of Measure: points on a scale of 30 (most satisfied)
26.88  (3.04) 25.21  (2.64)
3.Primary Outcome
Title Qualitative Assessment of Genetic Counseling Experience, Barriers and Facilitators by PATIENTS
Hide Description 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.
Time Frame Within six weeks of receiving genetic counseling
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Videoconferencing Genetic Consultation Teleconferencing Genetic Consultation
Hide Arm/Group Description:

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

Patients will receive genetic counseling session via telephone (usual treatment)

Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)

Overall Number of Participants Analyzed 7 6
Measure Type: Number
Unit of Measure: participants
NA [1]  NA [1] 
[1]
The data is qualitative in nature collected via interview
4.Primary Outcome
Title Qualitative Assessment of Genetic Counseling Experience, Barriers and Facilitators by GENETIC COUNSELORS
Hide Description 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.
Time Frame Within 4 weeks after study data collection was completed
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Videoconferencing Genetic Consultation Teleconferencing Genetic Consultation
Hide Arm/Group Description:
Counselors provided genetic counseling via videoconferencing.
Counselors provided genetic counseling via telephone.
Overall Number of Participants Analyzed 5 5
Measure Type: Count of Participants
Unit of Measure: Participants
NA [1]  NA [1] 
[1]
Data is qualitative in nature and collected via interview.
5.Primary Outcome
Title Cost Analysis
Hide Description 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.
Time Frame Cost analysis will be conducted in months 10-12 of grant period (projected January 1-March 31, 2015)
Hide Outcome Measure Data
Hide Analysis Population Description
Travel distance data not applicable to the Teleconferencing group.
Arm/Group Title Videoconferencing Genetic Consultation Teleconferencing Genetic Consultation
Hide Arm/Group Description:

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

Patients will receive genetic counseling session via telephone (usual treatment)

Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)

Overall Number of Participants Analyzed 8 0
Median (Inter-Quartile Range)
Unit of Measure: Loss of Productivity Cost in US Dollars
67.29
(44.78 to 97.88)
Time Frame [Not Specified]
Adverse Event Reporting Description There were no participants affected by any serious Adverse Events
 
Arm/Group Title Videoconferencing Genetic Consultation Teleconferencing Genetic Consultation
Hide Arm/Group Description

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

Patients will receive genetic counseling session via telephone (usual treatment)

Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)

All-Cause Mortality
Videoconferencing Genetic Consultation Teleconferencing Genetic Consultation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Videoconferencing Genetic Consultation Teleconferencing Genetic Consultation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Videoconferencing Genetic Consultation Teleconferencing Genetic Consultation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/19 (0.00%) 
We did not achieve the study sample that we hoped to achieve. Patients randomized to the telephone arm participated in the study, whereas patients randomized to the videoconferencing arm often dropped out of the study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Santanu Datta, Health Sciences Research Specialist, HSR&D
Organization: Health Services Research & Development, Durham VAMC
Phone: (919) 286-0411 ext 7580
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02108977     History of Changes
Other Study ID Numbers: PPO 13-364
First Submitted: March 31, 2014
First Posted: April 9, 2014
Results First Submitted: April 8, 2016
Results First Posted: April 21, 2016
Last Update Posted: March 28, 2019