Alzheimer DiseaseCONNECT4APOENCT02978729
Telephone Versus Videoconference Communication for Remote Genetic Disclosure in the APOE4 Trial
A study testing Two-way videoconference remote genetic counseling and Telephone remote genetic counseling in people with Alzheimer Disease and Genetic Predisposition to Disease, run by University of Pennsylvania.
Trial summary
The purpose of this study is to compare two methods for remote genetic counseling (telephone and two-way videoconferencing) for patients who are receiving disclosure of their APOE (apolipoprotein E) genotype. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Genetic Predisposition to Disease
- What is being tested?
- Two-way videoconference remote genetic counseling and Telephone remote genetic counseling
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 613 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to 11 Jul 2019
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible to participate in the Generation Study
- Ability to provide consent
- Ability to communicate and hear in English
Who cannot join
- -
About this study
Official title: A Randomized Study of Telephone Versus Videoconference Communication for Remote Genetic Disclosure in the APOE4 Trial
The purpose of this study is to compare two methods for remote genetic counseling (telephone and two-way videoconferencing) for patients who are receiving disclosure of their APOE (apolipoprotein E) genotype. The target population will consist of males and females in the age range of 60-75 years who, as potential participants in a study (Generation Study), will need to receive genetic counseling and disclosure of APOE genotype. Subjects must be willing to receive genetic counseling and disclosure remotely. Subjects must be willing to be randomized to either telephone arm or videoconference arm.
- Being tested
- Two-way videoconference remote genetic counseling, Telephone remote genetic counseling
- Keywords
- Telemedicine, Counseling, Genetic
- Medical subject headings
- Alzheimer Disease, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-way videoconference remote genetic counselingOther
Telephone remote genetic counselingOther
| Study group | Role | What they receive |
|---|---|---|
| Telephone | Active comparator | Telephone telegenetics counseling: A trained Penn genetic counselor will conduct genotype disclosure visits with the participant via telephone. The participant will be in a private room at the study site. Telephone sessions will utilize a private phone line. The genetic counselor will use standardized disclosure checklist and visual aids for the disclosure session. Receives: Other: Telephone remote genetic counseling |
| Videoconference | Experimental | Two-way videoconferencing telegenetics counseling: A trained Penn genetic counselor will conduct genotype disclosure visits with the participant via two-way videoconferencing. The participant will be in a private room at the study site. Videoconferencing sessions will utilize tablets or laptops with web cameras and secure/confidential software for teleconferencing. The genetic counselor will use standardized disclosure checklist and visual aids for the disclosure session. Receives: Other: Two-way videoconference remote genetic counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with genetic counseling services as measured by the Satisfaction with Genetic Services Scale
Measured: 2-7 days
Satisfaction with genetic counseling services as measured by the Satisfaction with Remote Counseling Scale
Measured: 2-7 days
Secondary outcomes (7)
Knowledge of Genetic Disease as measured by the Cancer Genetics Knowledge Scale
Measured: 2-7 days, 6 weeks, 6 months, 12 months
Disease-specific distress as measured by the Impact of Events Scale
Measured: 2-7 days, 6 weeks, 6 months, 12 months
Perceived risk of Alzheimers Disease as measured by questionnaire items measuring perceived risk in quantitative, qualitative, and relative terms
Measured: 2-7 days, 6 weeks, 6 months, 12 months
Responses to Genetic Testing as measured by the Impact of Genetic Testing for Alzheimer's disease (IGT-AD) scale
Measured: 2-7 days, 6 weeks, 6 months, 12 months
Depression as measured by the GDS Short Form
Measured: 2-7 days, 6 weeks, 6 months, 12 months
Anxiety as measured by the Mini State Trait Anxiety Inventory (mSTAI):
Measured: 2-7 days, 6 weeks, 6 months, 12 months
Knowledge of Genetic Disease as measured by the ClinSeq Knowledge Scale
Measured: 2-7 days, 6 weeks, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startAug 2016
- Primary completion11 Jul 2019
- Study completion11 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 613 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela R Bradbury, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978729
- Sponsor's protocol ID
- 824225
- Acronym
- CONNECT4APOE
- Status last verified
- Nov 2020
- First submitted
- 7 Nov 2016
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Telephone Versus Videoconference Communication for Remote Genetic Disclosure in the APOE4 Trial
- ClinicalTrials.gov ID
- NCT02978729
- Acronym / sponsor ID
- CONNECT4APOE / 824225
- Keywords
- Telemedicine, Counseling, Genetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 613 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 11 Jul 2019 (actual)
- Study completion
- 11 Jul 2019 (actual)
- First posted
- 1 Dec 2016 (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.
The purpose of this study is to compare two methods for remote genetic counseling (telephone and two-way videoconferencing) for patients who are receiving disclosure of their APOE (apolipoprotein E) genotype. The target population will consist of males and females in the age range of 60-75 years who, as potential participants in a study (Generation Study), will need to receive genetic counseling and disclosure of APOE genotype. Subjects must be willing to receive genetic counseling and disclosure remotely. Subjects must be willing to be randomized to either telephone arm or videoconference arm.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone | Active comparator | Other: Telephone remote genetic counselingTelephone telegenetics counseling: A trained Penn genetic counselor will conduct genotype disclosure visits with the participant via telephone. The participant will be in a private room at the study site. Telephone sessions will utilize a private phone line. The genetic counselor will use standardized disclosure checklist and visual aids for the disclosure session. |
| Videoconference | Experimental | Other: Two-way videoconference remote genetic counselingTwo-way videoconferencing telegenetics counseling: A trained Penn genetic counselor will conduct genotype disclosure visits with the participant via two-way videoconferencing. The participant will be in a private room at the study site. Videoconferencing sessions will utilize tablets or laptops with web cameras and secure/confidential software for teleconferencing. The genetic counselor will use standardized disclosure checklist and visual aids for the disclosure session. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eligible to participate in the Generation Study
- Ability to provide consent
- Ability to communicate and hear in English
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Two-way videoconference remote genetic counseling | Other | Videoconference |
| Telephone remote genetic counseling | Other | Telephone |
Primary outcome
Satisfaction with genetic counseling services as measured by the Satisfaction with Genetic Services Scale
Time frame: 2-7 days
Satisfaction with genetic counseling services as measured by the Satisfaction with Remote Counseling Scale
Time frame: 2-7 days
7 secondary outcomes
Knowledge of Genetic Disease as measured by the Cancer Genetics Knowledge Scale
Time frame: 2-7 days, 6 weeks, 6 months, 12 months
Disease-specific distress as measured by the Impact of Events Scale
Time frame: 2-7 days, 6 weeks, 6 months, 12 months
Perceived risk of Alzheimers Disease as measured by questionnaire items measuring perceived risk in quantitative, qualitative, and relative terms
Time frame: 2-7 days, 6 weeks, 6 months, 12 months
Responses to Genetic Testing as measured by the Impact of Genetic Testing for Alzheimer's disease (IGT-AD) scale
Time frame: 2-7 days, 6 weeks, 6 months, 12 months
Depression as measured by the GDS Short Form
Time frame: 2-7 days, 6 weeks, 6 months, 12 months
Anxiety as measured by the Mini State Trait Anxiety Inventory (mSTAI):
Time frame: 2-7 days, 6 weeks, 6 months, 12 months
Knowledge of Genetic Disease as measured by the ClinSeq Knowledge Scale
Time frame: 2-7 days, 6 weeks, 6 months, 12 months
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 19 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Alzheimer Disease
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis
Recruiting
Identification of Diagnosis Biomarkers in the Tears of Alzheimer's Disease Patients: The COG-EYE Pilot Study
Alzheimer Disease
Active, not recruitingPhase 2
A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
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.
Angela R Bradbury, MD principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A study testing Two-way videoconference remote genetic counseling and Telephone remote genetic counseling in people with Alzheimer Disease and Genetic Predisposition to Disease, run by University of Pennsylvania.
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 3 inclusion and 1 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 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Satisfaction with genetic counseling services as measured by the Satisfaction with Genetic Services Scale (time frame: 2-7 days). The study lists 2 primary outcomes in all. 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 19 Nov 2020; AzTrials last refreshed its copy on 6 Nov 2026.