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Trial of Ascertaining Individual Preferences for Loved One's Role in End-of-Life
NCT01160367 · View on ClinicalTrials.gov ↗
Study Summary
Specific Aims and Hypotheses: Aim 1: To test the effect of the "Trial of Ascertaining Individual preferences for Loved Ones' Role in End-of-life Decisions" (TAILORED) Intervention on family decision-making self-efficacy at 8 weeks both with respect to the patient's present situation and in a hypothetical situation in which the patient lacks decision-making capacity. Hypotheses 1a: Family decision-making self-efficacy will be greater at 8 weeks in pairs that have undergone the TAILORED Intervention than in pairs receiving the standard information on advance directives in the patient's present situation. Hypotheses 1b: Family decision-making self-efficacy will be greater at 8 weeks in pairs that have undergone the TAILORED Intervention than in pairs receiving the standard information on advance directives in the hypothetical situation in which the patient lacks decision making capacity. Aim 2: To test the effect of the TAILORED Intervention on family psychological outcomes (depression, caregiver burden, decision making distress). Hypotheses 2a: Depression will be less at 8 weeks in family members who have undergone the TAILORED Intervention than in family members who have received the standard information on advance directives. Hypotheses 2b: Caregiver burden will be less at 8 weeks in family members who have undergone the TAILORED Intervention than in family members who have received the standard information on advance directives. Hypotheses 2c: Decision-making distress will be less at 8 weeks in family members who have undergone the TAILORED Intervention than in family members who have received the standard information on advance directives. Aim 3: To test the effect of the TAILORED Intervention on patient and family satisfaction with family decision-making involvement. Hypothesis 3a: Patient satisfaction with family decision involvement will be greater at 8 weeks in patients who have undergone the TAILORED Intervention than in patients receiving the standa
Conditions Studied
Interventions
- OTHER standard of care
- OTHER TAILORED Patient Family Decision Making
Study Locations (1)
Maryland
- Johns Hopkins University — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 431 participants |
| Start Date | 2010-08-26 |
| Est. Completion | 2014-03-26 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01160367
The ClinicalTrials.gov registry entry for NCT01160367 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 431 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,517 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Pancreatic Cancer appearing as the primary indexed condition, and to 2 interventions — of which standard of care is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01160367 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01160367 about?
NCT01160367 is a clinical study titled "Trial of Ascertaining Individual Preferences for Loved One's Role in End-of-Life". Specific Aims and Hypotheses: Aim 1: To test the effect of the "Trial of Ascertaining Individual preferences for Loved Ones' Role in End-of-life Decisions" (TAILORED) Intervention on family decision-making self-efficacy at 8 weeks both with respect to the patient's present situation and in a hypoth...
What is the current status of trial NCT01160367?
This trial is currently completed. It is a NA study. The enrollment target is 431 participants. The study started on 2010-08-26. Estimated completion is 2014-03-26.
What conditions does trial NCT01160367 study?
This clinical trial studies the following conditions: Pancreatic Cancer, Amyotrophic Lateral Sclerosis, GI Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01160367?
The interventions under investigation include: standard of care (OTHER), TAILORED Patient Family Decision Making (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01160367?
This trial is sponsored by Johns Hopkins University, which has 1,517 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01160367 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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