Clinical trial NCT04003493: LifE Style, Nutrition and Oral Health in Care Givers (LENTO)
Official title: LifE Style, Nutrition and Oral Health in Care Givers)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Disorders in Old Age
Caries,Dental
Dentures
Oral Mucositis
Tooth Diseases
Plaque, Dental
Gingival Diseases
Keywords: Nutrition
Oral health
Care givers
Home care clients
Quality of life
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
Collaborators: name: Kuopio University Hospital
First posted: 2019-07-01
Enrollment: 250
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* caregivers who have a caregiver´s contract valid on 1 January 2019
* care recipients living at home

Exclusion Criteria:

* in terminal care

Primary outcomes:
measure: Nutritional status
timeFrame: Baseline and 6 months and (12 months follow-up visit)
measure: Albumin
timeFrame: Baseline and 6 months and (12 months follow-up visit)
measure: Prealbumin
timeFrame: Baseline and 6 months and (12 months follow-up visit)
measure: Body mass index (kg/m2)
timeFrame: Baseline and 6 months and (12 months follow-up visit)
measure: Hand grip strength
timeFrame: Baseline and 6 months and (12 months follow-up visit)
measure: Number and location of teeth
timeFrame: Baseline and 6 months and (12 months follow-up visit)
measure: Type and location of removable dental prosthesis
timeFrame: Baseline and 6 months and (12 months follow-up visit)
measure: Oral mucosa
timeFrame: Baseline and 6 months and (12 months follow-up visit)
measure: Condition of teeth
timeFrame: Baseline and 6 months and (12 months follow-up visit)
measure: Presence of plaque
timeFrame: Baseline and 6 months and (12 months follow-up visit)
measure: Gingival bleeding and measurement of periodontal pockets
timeFrame: Baseline and 6 months and (12 months follow-up visit)
measure: Dental and denture hygiene
timeFrame: Baseline and 6 months and (12 months follow-up visit)
measure: Subjective feeling of dry mouth and pain in mouth
timeFrame: Baseline and 6 months and (12 months follow-up visit)
Secondary outcomes:
measure: Activities of Daily Living
timeFrame: Baseline and 6 months and (12 months follow-up visit)
measure: Instrumental Activities of Daily Living
timeFrame: Baseline and 6 months and (12 months follow-up visit)
measure: Quality of Life (WHOQOL) -bref scores
timeFrame: Baseline and 6 months and (12 months follow-up visit)
measure: Depression
timeFrame: Baseline and 6 months and (12 months follow-up visit)
measure: Cognition
timeFrame: Baseline and 6 months and (12 months follow-up visit)
measure: Sense of coherence
timeFrame: Baseline and 6 months and (12 months follow-up visit)
measure: Morbidity
timeFrame: Baseline
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: University of Eastern Finland
Study officials:
affiliation: Study Principal Inverstigator, professor
name: Ursula o Schwab, PhD
role: STUDY_DIRECTOR
affiliation: Study Principal Inverstigator, professor
name: Liisa o Suominen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Study Principal Inverstigator, adjuct professor
name: Tarja o Välimäki, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Study Principal Investigator, adjuct professor
name: Irma o Nykänen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koponen S, Nykanen I, Savela RM, Valimaki T, Suominen AL, Schwab U. Individually tailored nutritional guidance improved dietary intake of older family caregivers: a randomized controlled trial. Eur J Nutr. 2022 Oct;61(7):3585-3596. doi: 10.1007/s00394-022-02908-w. Epub 2022 May 27.
citation: Nykanen I, Valimaki T, Suominen L, Schwab U. Optimizing nutrition and oral health for caregivers-intervention protocol. Trials. 2021 Sep 15;22(1):625. doi: 10.1186/s13063-021-05589-8.