LifE Style, Nutrition and Oral Health in Care Givers (LENTO)

Oral Mucositis Clinical Trial

Official title:

LifE Style, Nutrition and Oral Health in Care Givers)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04003493
• Other study ID #: LENTO
• Status: Completed
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2021
• Source: University of Eastern Finland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The LENTO study sample includes the caregivers and their clients living in eastern Finland. The aims of this study are

1. to study the nutritional status, oral health, coping, functional capacity and quality of life

2. to find out how individual nutrition and oral health counseling received for caregivers affect on the nutritional status and oral health of caregivers and their clients

3. develop an operating model to maintain good nutrition and oral health.

Description:

In Finland, the aim is to reduce the institutional care of older people and caring them in their own homes. The goal of shifting the focus of services to open services is difficult to implement if the health of the caregivers is inadequate. In order to achieve this goal, it is important to influence the health and performance of caregivers. Information is needed to support this, among others, about how the nutrition and oral health of caregivers can be promoted and to what extent this affects the performance and quality of life of their clients. A randomly of 220 caregivers over 65 years old and their clients is selected for this study. The caregivers are randomized to either treatment or control groups. At the beginning of the study is estimated the nutritional status and oral health of the caregivers. Based on the results, the nutritionist and dental hygienist give individual advice to optimize the nutrition and oral health of the caregivers in the intervention group. After six months, the same measurements are made as at the beginning of the study. Monitoring measurements will be made one year after the start of the intervention. The results of this project provide information on the health, well-being, and ability to the function of the caregivers. Based on the results, is developed an operating model that is intended to be wide as use as possible. Improving the nutrition and oral health of caregivers has a significant impact on their own and their clients health and well-being as well as the long-term care costs presumably.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• caregivers who have a caregiver´s contract valid on 1 January 2019

• care recipients living at home

Exclusion Criteria:

• in terminal care

Related Conditions & MeSH terms

• Caries,Dental
• Dental Caries
• Dental Plaque
• Dentures
• Gingival Diseases
• Mucositis
• Nutrition Disorders
• Nutrition Disorders in Old Age
• Oral Mucositis
• Plaque, Dental
• Stomatitis
• Tooth Diseases

Intervention

Other:
• Nutrition and oral health intervention
The interventions included individualised nutrition and oral health care.

Locations

Country	Name	City	State
Finland	University of Eastern Finland	Kuopio

Sponsors (2)

Lead Sponsor	Collaborator
University of Eastern Finland	Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional status	Change in MNA scores	Baseline and 6 months and (12 months follow-up visit)
Primary	Albumin	Change in plasma albumin concentration	Baseline and 6 months and (12 months follow-up visit)
Primary	Prealbumin	Change in plasma prealbumin concentration	Baseline and 6 months and (12 months follow-up visit)
Primary	Body mass index (kg/m2)	Change in BMI	Baseline and 6 months and (12 months follow-up visit)
Primary	Hand grip strength	Change in had grip strength of boot hands	Baseline and 6 months and (12 months follow-up visit)
Primary	Number and location of teeth	Change in number and location of teeth	Baseline and 6 months and (12 months follow-up visit)
Primary	Type and location of removable dental prosthesis	Change in type and location of removable dental prosthesis	Baseline and 6 months and (12 months follow-up visit)
Primary	Oral mucosa	Change in oral mucosa	Baseline and 6 months and (12 months follow-up visit)
Primary	Condition of teeth	Change in condition of teeth	Baseline and 6 months and (12 months follow-up visit)
Primary	Presence of plaque	Change in presence of plaque	Baseline and 6 months and (12 months follow-up visit)
Primary	Gingival bleeding and measurement of periodontal pockets	Change in gingival bleeding and measurement of periodontal pockets	Baseline and 6 months and (12 months follow-up visit)
Primary	Dental and denture hygiene	Change dental and denture hygiene	Baseline and 6 months and (12 months follow-up visit)
Primary	Subjective feeling of dry mouth and pain in mouth	Change in subjective feeling of dry mouth and pain in mouth	Baseline and 6 months and (12 months follow-up visit)
Secondary	Activities of Daily Living	Change in Activities of Daily Living (ADL) scores	Baseline and 6 months and (12 months follow-up visit)
Secondary	Instrumental Activities of Daily Living	Change in Instrumental Activities of Daily Living (IADL) scores	Baseline and 6 months and (12 months follow-up visit)
Secondary	Quality of Life (WHOQOL) -bref scores	Change in quality of Life (WHOQOL) -bref scores	Baseline and 6 months and (12 months follow-up visit)
Secondary	Depression	Change in Geriatric Depression Scale (GDS)-15 scores	Baseline and 6 months and (12 months follow-up visit)
Secondary	Cognition	Change in Mini Mental State Examination (MMSE) scores	Baseline and 6 months and (12 months follow-up visit)
Secondary	Sense of coherence	Change in sense of coherence (SOC) scores	Baseline and 6 months and (12 months follow-up visit)
Secondary	Morbidity	Functional Comorbidity Index (FCI) scores	Baseline