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Amish/Mennonite Research Contact Registry

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02990572
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : January 22, 2021
Information provided by (Responsible Party):
Lina Ghaloul Gonzalez, University of Pittsburgh

Brief Summary:
The purpose of this registry is to find members of the Plain Community who are interested in participating in future medical research studies. Having a registry makes it easier to contact and offer study participation to individuals who are appropriate for a new research study based on their own and their family medical history. Studies will focus on increasing knowledge about disorders affecting those who are Amish and Mennonite.

Condition or disease

Detailed Description:

The Amish and Mennonite communities of western Pennsylvania are unique because they are isolated both geographically and socially. These groups originally migrated as a small group from Europe. Since this first settlement there have been additional migration events within North America that have resulted in many distinct communities. These events lead to genetic founder effects, genetic bottleneck effects and virtually zero genetic inflow. The result has been an increased burden of genetic disease on these vulnerable communities. Specific founder genes explain the prevalence of different genetic conditions within each community and family group. This means that families and communities will have a clustering of certain genetic conditions, while the prevalence among the Plain people as a whole remains low. Understanding the specific needs of each family and community group is important in order to deliver comprehensive and specialized care. This requires research studies and needs assessments within these communities. Currently this need is being addressed in eastern Pennsylvania by the Clinic for Special Children in Strasburg. This organization has conducted research to improve access and quality of care for these Plain Communities. There is an apparent need for a similar understanding and relationship with the Plain Communities of western Pennsylvania.

Currently, a barrier exists for identifying and ascertaining appropriate individuals within the Plain Community for new research studies. This is largely due to their social and geographical isolation related to religious and cultural practices. Improving research and understanding within Plain Communities has the potential to improve early diagnosis, interventions, and clinical outcomes. Creating an ongoing registry will moderate these barriers and provide a platform for contacting willing members of the Plain Community for participation in future research projects that may positively impact their medical care, as well as the general care in their communities.

This is not a study but a registry. Potential participants will be educated about the intent of the registry, and written informed consent will be obtained to allow for collection and storage of information in the registry for an indefinite period of time. At the time of consent, potential participants will be informed about what it means to be a part of the registry and the potential for contact and recruitment to future research studies.

One-on-one interviews with a clinician, or with primary and co-investigators, will be conducted. This interview may take place in a clinic setting or the participants home or regional environment. The primary goal of the interview will be to collect a detailed family and medical history of each participant. This will be used to build a detailed pedigree of members of this community. Medical information obtained through released medical records will be included in the registry. Basic demographic and contact information will also be included in the registry.

Subjects information will be stored in the host PhenoTips database and data will be regularly undated and reviewed. Participants may be contacted for future research studies.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 100 Years
Official Title: Research Contact Registry for Members of the Amish and Mennonite Communities
Study Start Date : October 2016
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2030

Amish and Mennonite
  • Agree to allow access to past, current, and future medical records
  • Provide a detailed family health history
  • Provide contact information that may be used for future approach regarding research studies

Primary Outcome Measures :
  1. Accumulation and clinical definition of a patient population who are willing to participate in future research studies for which they are eligible. [ Time Frame: This registry is intended to be an ongoing resource for recruitment into future research studies and will be maintained up to 14 years. ]
    This research registry is intended to allow for identification of patients from the Plain Communities who are willing to participate in medical research. Eligibility for each future study will likely cary and patients will be selected and contacted with their permission, by dint of having consented to this registry, about the option of participating in a new research study.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Amish and Mennonite

Inclusion Criteria:

  • Amish and Mennonite men and women age 18 or older
  • Amish and Mennonite children with the permission of a parent

Exclusion Criteria:

  • Amish and Mennonite men and woman age 18 or older who do not speak English
  • Those who are not Amish or Mennonite

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02990572

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Contact: Cate Walsh Vockley, MS, LCGC 412-692-7349
Contact: Lina Ghaloul Gonzalez, MD, PhD

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United States, Pennsylvania
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Cate Walsh Vockley, MS, LCGC    412-692-7349   
Contact: Lina Ghaloul Gonzalez, MD, PhD   
Sponsors and Collaborators
University of Pittsburgh
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Principal Investigator: Lina Ghaloul Gonzalez, MD, PhD University of Pittsburgh
Additional Information:

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Responsible Party: Lina Ghaloul Gonzalez, Research Assistant Professor, Medical Genetics, University of Pittsburgh School of Medicine, University of Pittsburgh Identifier: NCT02990572    
Other Study ID Numbers: PRO16030311
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lina Ghaloul Gonzalez, University of Pittsburgh: