NCT06984042

Brief Summary

This study aims to improve the way pain is managed in nursing homes. It focuses on training staff, creating better systems to track pain, and involving residents and their families in decision-making. The goal is to provide better, more personalized care for residents, making sure their pain is properly managed and that the staff is well-equipped to support them.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

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

Study Start

First participant enrolled

July 20, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 22, 2025

Completed
Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

May 14, 2025

Last Update Submit

May 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion (%) of residents with regular documentation of pain assessment in the Electronic Health Record

    Over a 4-month study period (from June to October 2024).

Study Arms (3)

Residents of EHPAD

2 residents

Family or close

2 family members or close

Healthcare professionals

1 psychologist, 1 head of department, 1 health manager, 2 IDE, 2 AS, 2 AVS and 1 quality engineer.

Eligibility Criteria

Age60 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will be selected from three main groups associated with nursing homes (EHPADs): Residents aged 60 years or older, who have been living in the EHPAD for at least 3 months and are experiencing chronic or acute pain requiring regular management. These residents must be capable of giving informed consent and willing to participate in semi-structured interviews. Family members or close relatives of residents, who are regularly involved in the resident's life and support, and who are willing and able to participate in interviews and discussions related to the study. Healthcare professionals working in the EHPAD, including registered nurses (IDE), nursing assistants (AS), care support staff (AVS), nurse managers, department heads, psychologists, and quality engineers. Participants must be directly involved in care or organizational activities, and available to take part in the full scope of the study.

You may qualify if:

  • For residents:
  • Aged 60 years or older
  • Living in the nursing home (EHPAD) for at least 3 months
  • Presence of chronic or acute pain requiring regular management
  • Willing to participate in a semi-structured interview
  • Provided informed and signed consent to participate in the study
  • For family members or close relatives:
  • Family member or close relative who visits the resident regularly
  • Actively involved in the resident's care or support
  • Willing to participate in a semi-structured interview
  • Provided informed consent to participate in the study
  • For healthcare professionals:
  • Registered nurses (RN), nursing assistants (NA), or support staff (AVS) involved in professional practice analysis groups
  • Nurse managers, department heads, psychologists of the nursing home, or the hospital's quality engineer participating in semi-structured interviews
  • Voluntary participation with informed and signed consent
  • +1 more criteria

You may not qualify if:

  • For residents:
  • Under 60 years of age
  • Living in the nursing home for less than 3 months
  • Absence of pain requiring regular management
  • Cognitive impairment preventing participation in interviews
  • Refusal or inability to participate in discussion and exchange sessions
  • Unwillingness to take part in a semi-structured interview
  • Inability to provide informed and signed consent
  • Resident in end-of-life care
  • For family members or close relatives:
  • Family member or relative with infrequent contact with the resident
  • Refusal or inability to participate in discussion and exchange sessions
  • Refusal to sign informed consent for participation
  • Unwillingness to take part in a semi-structured interview
  • For healthcare professionals:
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

France

Gonesse, France

Location

MeSH Terms

Conditions

AgnosiaPain

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2025

First Posted

May 22, 2025

Study Start

July 20, 2024

Primary Completion

November 20, 2024

Study Completion

November 20, 2024

Last Updated

May 22, 2025

Record last verified: 2025-05

Locations