NCT03605420

Brief Summary

The present study evaluates the effects of the visit prior to hospital admission on anxiety, depression and satisfaction of family in an intensive care unit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
23 days until next milestone

Study Start

First participant enrolled

August 22, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2019

Completed
Last Updated

January 28, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

July 21, 2018

Last Update Submit

January 25, 2019

Conditions

AnxietyDepressionCare Unit Syndrome

Outcome Measures

Primary Outcomes (1)

  • The Hospital Anxiety and Depression Scale

    Anxiety subscale range from 0 to 21. Depression subscale range from 0 to 21. Higher values represent a worse outcome (higher depression or anxiety).

    Change from Baseline anxiety and depression at 90 days

Study Arms (2)

Experimental group

EXPERIMENTAL

Receiving one family visit prior to hospital admission

Other: Family visit prior to hospital admission

Control group

NO INTERVENTION

Without receiving one family visit prior to hospital admission

Interventions

Family visit prior to hospital admissionOTHER

Family receiving one visit prior to hospital admission for surgery

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Family of a patient for hospital admission for surgery

You may not qualify if:

  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital La Princesa

Madrid, 28006, Spain

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MSc, PT

Study Record Dates

First Submitted

July 21, 2018

First Posted

July 30, 2018

Study Start

August 22, 2018

Primary Completion

January 20, 2019

Study Completion

January 25, 2019

Last Updated

January 28, 2019

Record last verified: 2019-01

Locations

ES(1)