The Impact of a Self-help Coping App on Distress Levels in Men Experiencing Infertility
Primary Purpose
Stress Reduction
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FertiStrong App
Sponsored by
About this trial
This is an interventional supportive care trial for Stress Reduction focused on measuring Infertility, Distress, Coping, Men
Eligibility Criteria
Inclusion Criteria:
- All men who are receiving care, or whose partner is receiving care, at Fertility Centers of Illinois during the study period.
Exclusion Criteria:
- Does not have daily access to a smart phone
- Does not read or understand English
Sites / Locations
- Fertility Centers of IllinoisRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Treatment Group
Control Group
Arm Description
Participants who are in the intervention group will receive the FertiStrong app downloading instructions as soon as they have been randomized. They will have access to this app for a period of 30 days during the intervention phase of the study.
Participants in the control group will not have access to the FertiStrong app for the first 30 days. After a period of 30 days, participants will be provided downloading instructions to this app.
Outcomes
Primary Outcome Measures
Anxiety and Depression in Men Experiencing Infertility
Evaluation of pre and post Hospital Anxiety and Depression Scores
Secondary Outcome Measures
Stress Levels in Men Experiencing Infertility
Fertility related distress will be measured using the Fertility Problem inventory (FPI)
Full Information
NCT ID
NCT03519607
First Posted
April 6, 2018
Last Updated
May 7, 2018
Sponsor
Fertility Centers of Illinois
1. Study Identification
Unique Protocol Identification Number
NCT03519607
Brief Title
The Impact of a Self-help Coping App on Distress Levels in Men Experiencing Infertility
Official Title
The Impact of a Self-help Coping App on Distress Levels in Men Experiencing Infertility
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fertility Centers of Illinois
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if the use of a new app, FertiStrong, is associated with decreased levels of anxiety and depression in men who have infertility or whose partner has infertility.
Detailed Description
Individuals who are experiencing infertility report high levels of anxiety and depression. A recent study (1) documented that both men and women involved in the treatment of infertility expressed emotional distress. Research on the female partner of an infertile couple documents that psychological interventions, especially those with a cognitive-behavior therapy (CBT) focus, are associated with significant decreases in levels of anxiety and depression (2). Subsequent research has also shown that both members of the infertile couple definitively underutilize the psychological services offered to them. Thus, new ways to provide psychological relief to these individuals is needed. This has lead to the development of a new app, FertiStrong. This app is targeted at men- either men with infertility or men whose partner has infertility.
Study Requirements:
Study participants will be asked to complete an on-line questionnaire.
Once completed, the study participant will be randomly assigned to one of two groups. One group will be provided the mobile app to use for 30 days. The second group will be provided the app after 30 days.
After the 30 day period, each group will be asked to complete a follow-up questionnaire. Each questionnaire will take approximately 15-20 minutes to compete.
Men who are directly seeking care or whose partners is seeking care at any Fertility Center of Illinois location are invited to participate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Reduction
Keywords
Infertility, Distress, Coping, Men
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Comparison of distress scores between the intervention group and the control group
Masking
Outcomes Assessor
Masking Description
Participant assignment will be masked for data analysis
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Active Comparator
Arm Description
Participants who are in the intervention group will receive the FertiStrong app downloading instructions as soon as they have been randomized. They will have access to this app for a period of 30 days during the intervention phase of the study.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants in the control group will not have access to the FertiStrong app for the first 30 days. After a period of 30 days, participants will be provided downloading instructions to this app.
Intervention Type
Behavioral
Intervention Name(s)
FertiStrong App
Other Intervention Name(s)
FertiStrong
Intervention Description
The FertiStrong mobile app is similar to FertiCalm, which is designed for women with infertility. FertiCalm (www.FertiCalm.com) can be downloaded for free anywhere in the US, for both Apple and Android phones. Each app contains twelve main categories and each main category contains up to five tailored situations. For each situation, there are six options. Three of the options are the same for all situations (humor, self-nurture, relaxation) and three are unique (cognitive solutions, behavioral solutions, social solutions).
Primary Outcome Measure Information:
Title
Anxiety and Depression in Men Experiencing Infertility
Description
Evaluation of pre and post Hospital Anxiety and Depression Scores
Time Frame
6 months post study completion
Secondary Outcome Measure Information:
Title
Stress Levels in Men Experiencing Infertility
Description
Fertility related distress will be measured using the Fertility Problem inventory (FPI)
Time Frame
6 months post study completion
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Males experiencing infertility, or men whose partner is experiencing infertility
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All men who are receiving care, or whose partner is receiving care, at Fertility Centers of Illinois during the study period.
Exclusion Criteria:
Does not have daily access to a smart phone
Does not read or understand English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Jasulaitis, CRC
Phone
(847) 916-6553
Email
Lauren.Jasulaitis@Integramed.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sue Jasulaitis, RN MSN
Phone
(847) 916-6297
Email
Sue.Jasulaitis@integramed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meike Uhler, MD
Organizational Affiliation
Fertility Centers of Illinois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fertility Centers of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Jasulaitis, CRC
Phone
847-916-6553
Email
Lauren.Jasulaitis@Integramed.com
First Name & Middle Initial & Last Name & Degree
Sue Jasulaitis, RN MSN
Phone
(847) 916-6297
Email
Sue.Jasulaitis@integramed.com
First Name & Middle Initial & Last Name & Degree
Meike Uhler, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Impact of a Self-help Coping App on Distress Levels in Men Experiencing Infertility
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