The Impact of a Self-help Coping App on Distress Levels in Men Experiencing Infertility
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2018
CompletedStudy Start
First participant enrolled
April 30, 2018
CompletedFirst Posted
Study publicly available on registry
May 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedMay 9, 2018
May 1, 2018
2 months
April 6, 2018
May 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anxiety and Depression in Men Experiencing Infertility
Evaluation of pre and post Hospital Anxiety and Depression Scores
6 months post study completion
Secondary Outcomes (1)
Stress Levels in Men Experiencing Infertility
6 months post study completion
Study Arms (2)
Treatment Group
ACTIVE COMPARATORParticipants 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.
Control Group
NO INTERVENTIONParticipants 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- All men who are receiving care, or whose partner is receiving care, at Fertility Centers of Illinois during the study period.
You may not qualify if:
- Does not have daily access to a smart phone
- Does not read or understand English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fertility Centers of Illinois
Chicago, Illinois, 60610, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meike Uhler, MD
Fertility Centers of Illinois
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Participant assignment will be masked for data analysis
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2018
First Posted
May 9, 2018
Study Start
April 30, 2018
Primary Completion
June 30, 2018
Study Completion
December 31, 2018
Last Updated
May 9, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share