NCT02825927

Brief Summary

The purpose of this study is to determine whether a specific rehabilitation program with oral screen used in an elderly population with dysphagia can improve elderly's swallowing capacity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

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

October 1, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

December 18, 2017

Status Verified

June 1, 2016

Enrollment Period

4.1 years

First QC Date

July 4, 2016

Last Update Submit

December 15, 2017

Conditions

DysphagiaDeglutition DisordersSwallowing DisordersQuality of Life

Keywords

DysphagiaOral screenInterventionOral HealthFood IntakeQuality of lifeElderlyShort-term care facilities

Outcome Measures

Primary Outcomes (1)

  • Swallowing function

    Change in swallowing function measured by the Swallowing Capacity Test (SCT) combined with a teaspoon test. Comparisons between intervention-and control group will be made.

    Baseline, 5 weeks and 6 months post-intervention

Secondary Outcomes (5)

  • Quality of life related to swallowing

    Baseline, 5 weeks and 6 months post-intervention

  • Oral Health

    Baseline, 5 weeks and 6 months post-intervention

  • Food Intake

    Baseline, 5 weeks and 6 months post-intervention

  • Activity of daily living

    Baseline, 5 weeks and 6 months post-intervention

  • Quality of life related to oral health

    Baseline, 5 weeks and 6 months post-intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Intensive training with oral screen for 5 weeks.

Other: Oral screen

Control group

NO INTERVENTION

The control group is not offered any intervention.

Interventions

Oral screenOTHER

The oral screen is used for 30 seconds, three times a day, before meals and implies new possibilities for training of the orofacial muscles.

Intervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age ≥ 65
  • Admitted to short-term care facility ≥ 3 days
  • Included in the overall project SOFIA and with a swallowing capacity \<10ml/sec

You may not qualify if:

  • Incapable of making decisions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Örebro län

Örebro, 701 11, Sweden

Location

Related Publications (3)

  • Hagglund P, Hagg M, Wester P, Levring Jaghagen E. Effects of oral neuromuscular training on swallowing dysfunction among older people in intermediate care-a cluster randomised, controlled trial. Age Ageing. 2019 Jul 1;48(4):533-540. doi: 10.1093/ageing/afz042.

    PMID: 31062842DERIVED

  • Hagglund P, Falt A, Hagg M, Wester P, Levring Jaghagen E. Swallowing dysfunction as risk factor for undernutrition in older people admitted to Swedish short-term care: a cross-sectional study. Aging Clin Exp Res. 2019 Jan;31(1):85-94. doi: 10.1007/s40520-018-0944-7. Epub 2018 Apr 16.

    PMID: 29663160DERIVED

  • Hagglund P, Olai L, Stahlnacke K, Persenius M, Hagg M, Andersson M, Koistinen S, Carlsson E. Study protocol for the SOFIA project: Swallowing function, Oral health, and Food Intake in old Age: a descriptive study with a cluster randomized trial. BMC Geriatr. 2017 Mar 23;17(1):78. doi: 10.1186/s12877-017-0466-8.

    PMID: 28335729DERIVED

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Eva Carlsson, PhD, Nurse

    Region Örebro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2016

First Posted

July 7, 2016

Study Start

October 1, 2013

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

December 18, 2017

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)