Clinical trial · Interventional
Family History App in Personalized Medicine
Family History App in Personalized Medicine (FHAMe): A Pilot Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A complete family history (FH) may identify persons at high risk for certain conditions. They can be offered genetic testing and life-saving screening and treatment. In practice, complete FH is rarely collected or entered into the electronic medical record (EMR). The Family History Screening Questionnaire is a survey patients complete to tell whether they are at increased risk of specific cancers, heart disease or diabetes. We will test a new way to record FH that includes an app to improve use of FH by family physicians and patients. The strategy includes education for patients and physicians about the importance of FH; patient completion of the FH questionnaire prior to appointments; and prompts in the EMR. We expect this to help family physicians and patients interpret FH and make the best decisions. We will assess the proportion of patients with new EMR FH information. We will explore if the strategy increases appropriate referrals for screening and genetic consultation for those at increased FH risk. We will also obtain patients' and physicians' feedback on this strategy. This new approach may improve FH information exchange between patients and physicians, encourage shared decision-making and reduce cancer deaths and chronic disease burden.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer, Colorectal | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Cancer, Ovarian | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Cancer, Prostate | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Coronary Artery Disease | — | UNRESOLVED | — |
| Diabetes Mellitus, Type 2 | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FHAMe Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- In addition to usual care, patients will be asked to answer questions about any family history through the use of a questionnaire.
- interventionNames
- Other: FHAMe Intervention
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- Patients receive usual care, which consists of health care providers inquiring about and dealing with family history as they would in usual practice.
Primary outcomes (6)
- measure
- Proportion of patients with new documentation of family history in EMR
- timeFrame
- 30 days post visit
- description
- The proportion of patients with new documentation of family history in the EMR within 30 days after the visit, compared to patients in control group practices
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * 30-69 years of age Exclusion Criteria: * Pregnancy * Must be patients of staff physicians (i.e. no resident patients) * Must have email address registered in the OCEAN system
References
Publications (1)
- DERIVEDCarroll JC, Greiver M, Kukan S, Bearss E, Walji S, Moineddin R, Aliarzadeh B, Kalia S, Allanson J, Grunfeld E, Gupta K, Heisey R, Kavanagh D, Kim R, Levy M, Morrison S, Muraca M, Mutasingwa D, O'Brien MA, Permaul J, Sullivan F, Wilson B. An Innovative Strategy for Collecting Family Health History: An Effectiveness-Implementation Trial in Primary Care Clinics. Ann Fam Med. 2025 Sep 22;23(5):399-406. doi: 10.1370/afm.240472. PMID 40983547