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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04003493
Other study ID # LENTO
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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 caregiverĀ“s contract valid on 1 January 2019 - care recipients living at home Exclusion Criteria: - in terminal care

Study Design


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
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