NCT05308862

Brief Summary

Inclusion criteria for study I and II is nurse aides, registered nurses and managers working in nursing homes who register in Senior Alert. To develop an intervention aiming to reduce the risk of pressure ulcers, malnutrition, poor oral health and falls among older persons in nursing homes, workshops will be conducted in collaboration with nurse aides, registered nurses and managers (study I). Cluster randomization is going to take place via a computerized program prior to the workshops meaning that only those nurse aides, registered nurses and managers working in nursing homes allocated to the intervention group are going to develop an intervention together with the research group and then test it (study II). The remaining nurse aides, registered nurses and managers working in nursing homes in the control group continue with regular care.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

January 19, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 23, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 9, 2025

Status Verified

May 1, 2025

Enrollment Period

4 years

First QC Date

February 23, 2022

Last Update Submit

May 7, 2025

Conditions

Keywords

PreventionOlder peopleNursing careComplex intervention

Outcome Measures

Primary Outcomes (16)

  • Risk assessments and prevention care interventions focusing on falls.

    Registry data from Senior Alert based on the following assessment: Downtown Fall Risk Index.

    Baseline 6 months prior to intervention

  • Risk assessments and prevention care interventions focusing on pressure ulcers.

    Registry data from Senior Alert based on the following assessment: The Modified Norton scale to measure risk for pressure ulcer.

    Baseline 6 months prior to intervention

  • Risk assessments and prevention care interventions focusing on malnutrition.

    Registry data from Senior Alert based on the following assessment: The Short Form-Mini Nutritional Assessment measure malnutrition.

    Baseline 6 months prior to intervention

  • Risk assessments and prevention care interventions focusing on poor oral health

    Registry data from Senior Alert based on the following assessment: The Revised Oral Assessment Guide (ROAG) to assess poor oral health.

    Baseline 6 months prior to intervention

  • Risk assessments and prevention care interventions focusing on falls.

    Registry data from Senior Alert based on the following assessment: Downtown Fall Risk Index.

    1 month after intervention

  • Risk assessments and prevention care interventions focusing on pressure ulcers.

    Registry data from Senior Alert based on the following assessment: The Modified Norton scale to measure risk for pressure ulcer.

    1 month after intervention

  • Risk assessments and prevention care interventions focusing on malnutrition.

    Registry data from Senior Alert based on the following assessment: The Short Form-Mini Nutritional Assessment measure malnutrition.

    1 month after intervention

  • Risk assessments and prevention care interventions focusing on poor oral health.

    Registry data from Senior Alert based on the following assessment: The Revised Oral Assessment Guide (ROAG) to assess poor oral health.

    1 month after intervention

  • Risk assessments and prevention care interventions focusing on falls.

    Registry data from Senior Alert based on the following assessment: Downtown Fall Risk Index.

    6 months after intervention

  • Risk assessments and prevention care interventions focusing on pressure ulcers.

    Registry data from Senior Alert based on the following assessment: The Modified Norton scale to measure risk for pressure ulcer.

    6 months after intervention

  • Risk assessments and prevention care interventions focusing on malnutrition.

    Registry data from Senior Alert based on the following assessment: The Short Form-Mini Nutritional Assessment measure malnutrition.

    6 months after intervention

  • Risk assessments and prevention care interventions focusing on poor oral health.

    Registry data from Senior Alert based on the following assessment: the Revised Oral Assessment Guide (ROAG) to assess poor oral health.

    6 months after intervention

  • Risk assessments and prevention care interventions focusing on falls.

    Registry data from Senior Alert based on the following assessment: Downtown Fall Risk Index.

    12 months after intervention

  • Risk assessments and prevention care interventions focusing on pressure ulcers.

    Registry data from Senior Alert based on the following assessment: The Modified Norton scale to measure risk for pressure ulcer.

    12 months after intervention

  • Risk assessments and prevention care interventions focusing on malnutrition.

    Registry data from Senior Alert based on the following assessment: The Short Form-Mini Nutritional Assessment measure malnutrition.

    12 months after intervention

  • Risk assessments and prevention care interventions focusing on poor oral health.

    Registry data from Senior Alert based on the following assessment: The Revised Oral Assessment Guide (ROAG) to assess poor oral health.

    12 months after intervention

Secondary Outcomes (3)

  • Perceived Stress Scale stress (PSS)

    Baseline and six months after intervention

  • Stress of Conscience (SCQ),

    Baseline and six months after intervention

  • Psychosocial Aspects of Job Satisfaction Questionnarie

    Baseline and six months after intervention

Other Outcomes (2)

  • Feasibility test of the co-created intervention designed to reduce the evidence-base practice gap regarding prevention of the risk for pressure ulcer, malnutrition, poor oral health and falls using questionnaire data

    Directly post intervention

  • Feasibility test of the co-created intervention designed to reduce the evidence-base practice gap regarding prevention of the risk for pressure ulcer, malnutrition, poor oral health and falls using interview data

    Directly post intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Cluster randomization is going to take place via a computerized program prior to the workshops meaning that only those nurse aides, registered nurses and managers working in nursing homes allocated to the intervention group are going to develop an intervention together with the research group and then test it.

Behavioral: Care process for assessements of risks

Control

NO INTERVENTION

Continue with usual care.

Interventions

Intervention aiming to reduce the risk of pressure ulcers, malnutrition, poor oral health and falls among older persons in nursing homes, workshops will be conducted in collaboration with nurse aides, registered nurses and managers. Cluster randomization is going to take place via a computerized program prior to the workshops meaning that only those nurse aides, registered nurses and managers working in nursing homes allocated to the intervention group are going to develop an intervention together with the research group and then test it .

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Nursing homes registering in Senior Alert, which is a national quality registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malin Axelsson

Malmo, 205 06, Sweden

RECRUITING

Related Publications (1)

  • Neziraj M, Axelsson M, Kumlien C, Hellman P, Andersson M. The STAIR OF KNOWLEDGE-a codesigned intervention to prevent pressure ulcers, malnutrition, poor oral health and falls among older persons in nursing homes in Sweden: development of a complex intervention. BMJ Open. 2023 Aug 10;13(8):e072453. doi: 10.1136/bmjopen-2023-072453.

MeSH Terms

Conditions

Pressure UlcerMalnutrition

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue DiseasesNutrition DisordersNutritional and Metabolic Diseases

Central Study Contacts

Malin Axelsson, Phd

CONTACT

Christine Kumlien, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 23, 2022

First Posted

April 4, 2022

Study Start

January 19, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 9, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations