NCT02926313

Brief Summary

A randomized control study aimed to investigate if suitable individualized seating provision is effective for adult nursing home residents in reducing the incidence of pressure ulcers, and increasing their quality of life and functioning.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

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

October 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
Last Updated

October 6, 2016

Status Verified

October 1, 2016

Enrollment Period

6 months

First QC Date

October 3, 2016

Last Update Submit

October 5, 2016

Conditions

Physical Disability

Keywords

RCTSpecialized seatingPressure ulcers

Outcome Measures

Primary Outcomes (3)

  • Change in the Braden Scale

    Measures the risk of developing pressure injuries/ ulcers

    Change in pressure injury risk from baseline at 12 weeks

  • Change in Oxygen saturation levels

    Pulse oximeter used to measure saturated oxygen levels

    Change in SpO2 levels from baseline at 12 weeks

  • Seating assessment

    This measures the individual's level of sitting skills and abilities

    baseline

Secondary Outcomes (2)

  • Change in sitting presentation - digitally captured

    Change in sitting presentation from baseline to 12 weeks

  • Change in Quality of life factors - questionnaire

    Change in quality of life from baseline to 12 weeks

Study Arms (2)

Existing Seating conditions

NO INTERVENTION

This group of participants received the standard care - they continue to sit in the seating system (chair and cushion) as provided by the nursing home facility staff; selected from whatever seats the facility had available.

Individualized Seating provision

EXPERIMENTAL

This group of participants were provided with a seating system that was specifically configured to match their individual postural care needs.

Other: Individualized Seating provision

Interventions

Individualized Seating provisionOTHER

Seating system selected and adjusted to meet individual needs.

Individualized Seating provision

Eligibility Criteria

Age44 Years - 98 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult living in one of the three nursing home facilities

You may not qualify if:

  • Determined to be at a high risk of developing pressure ulcers (as per Braden Scale assessment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2016

First Posted

October 6, 2016

Study Start

October 1, 2012

Primary Completion

April 1, 2013

Study Completion

August 1, 2013

Last Updated

October 6, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share