Developing the Family Map: Looking at Communal Coping

This study is currently recruiting participants.
Verified September 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01633021
First received: June 29, 2012
Last updated: March 14, 2014
Last verified: September 2013
  Purpose

Background:

- Knowing one s family medical history is a part of staying healthy. Some health risks run in families, and knowing these risks can promote more healthy behavior. Different social and cultural factors may affect how family members share this information. Genetic risk information that is shared in one family may not be shared in the same way in another. This information may also be shared differently between spouses, siblings, or parents and children. It may even be shared with more distant relatives. Knowing the information that family members share and how they share it may help researchers improve genetic disease treatment and support plans. Family surveys of people who have genetic health risks may help provide this information.

Objectives:

- To study how family members affected by genetic-related diseases share health information with each other.

Eligibility:

  • Individuals at least 18 years of age who can read English or Spanish.
  • Participants affected by a genetic disease or be related or married to someone who has the disease.

Design:

  • Participants will be screened with an initial questionnaire. They will identify their genetic disease and provide a basic health history.
  • Participants who have the disease will complete an online survey or participate in a personal interview. The questions will take about 45 minutes to 1 hour to answer. The survey will ask about family health history and family support. Participants will also provide referrals to a spouse or relatives who will participate in the study.
  • The spouse or relative will answer a similar survey. The survey will ask about health history and support for the spouse/relative with the disease.
  • A gift card will be given as thanks for participating in the study.

Condition
Diabetes
Cancer
Cardiovascular Disease

Study Type: Observational
Official Title: Development of the Family Map: Examination of Communal Coping Across Disease Context

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • The primary outcome of the current protocol is the development of a methodology to obtain an accurate representation of familial social structure in advance of intervention based on the responses of a few key informants

Estimated Enrollment: 4000
Study Start Date: June 2012
Detailed Description:

Facilitating the dissemination of disease risk information and promoting engagement in healthful behaviors within families may be enhanced by using network-based interventions. Networkbased interventions are innovative in that they are tailored to the structure of the social system within which individuals are embedded. Understanding the social and relational factors associated with processes of family risk information dissemination, family encouragement, and support is essential to developing network-based intervention tools targeting the family. The first objective of the current project is to ascertain those key social pathways that can be used in a family-centered network-based intervention that promotes disease prevention. To this end, efforts will be focused on assessing whether there is a consistent, small set of relational characteristics associated with the dissemination of family risk information and processes of both behavioral and emotional adaptation to disease risk across various disease and cultural contexts. The second objective is to examine the feasibility of using cognitive network approaches to assess social interactions among family members as a means to enhance the implementation of a network-based intervention. A cognitive network is an individual s perception of the relationships among their family (or network) members. Thus, cognitive network approaches can be used to capture an accurate representation of family social structure based on the information provided by a small subset of optimally-situated family members. Those key social pathways identified within the first objective of this research will be used to address the second objective. Families affected by diseases and disorders that span the spectrum of genetic penetrance, ranging from highly penetrant, monogenetic disease to less penetrant, common complex conditions, will be recruited for the study. Further, the current effort will seek to engage samples from diverse cultural backgrounds to address our limited knowledge regarding risk communication and adaptation in such families and to facilitate generalization of results. Study participants will be recruited from established cohorts or ongoing studies, both at the NIH and at extramural institutions. Family members will be recruited using a snowball sampling approach and will be asked to complete a web-based or telephone survey. The research addressed in this protocol will lead to the development of an innovative methodology with the potential to improve the design and implementation of family-based interventions that promote disease prevention.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:
  • Aged 18 years or older
  • Ability to complete web-based survey or telephone interview
  • Ability to read English or Spanish
  • Affected by or have at least one first- or second-degree relative affected by or have a spouse/partner affected by the disease(s) of interest.
  • Biological or non-biological (e.g. adopted or step) relative of the primary participant or spouse/partner of the primary participant or biological relative of primary participant.
  • Have at least two family members (biological or non-biological (e.g. adopted or step)relative or a spouse/partner) who are eligible for the study

EXCLUSION CRITERIA:

Individuals with cognitive difficulties will be excluded from the study, as participants will be required to comprehend and legally consent to participation in this study and complete the surveys.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633021

Contacts
Contact: Andrea F Goergen (301) 443-8185 goergena@mail.nih.gov
Contact: Laura M. Koehly, Ph.D. (301) 451-3999 koehlyl@mail.nih.gov

Locations
United States, Illinois
Rush Presbyterian St. Luke's Medical Center Recruiting
Chicago, Illinois, United States, 60612
United States, Maryland
National Human Genome Research Institute (NHGRI), 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229-3039
Sponsors and Collaborators
Investigators
Principal Investigator: Laura M. Koehly, Ph.D. National Human Genome Research Institute (NHGRI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01633021     History of Changes
Other Study ID Numbers: 999912149, 12-HG-N149
Study First Received: June 29, 2012
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Monogenetic and Complex Disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014