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

Sponsor
University of Eastern Finland (Other)
Overall Status
Completed
CT.gov ID
NCT04003493
Collaborator
Kuopio University Hospital (Other)
250
1
4
19.6
12.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Nutrition and oral health intervention
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
LifE Style, Nutrition and Oral Health in Care Givers)
Actual Study Start Date :
May 15, 2019
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group of nutrition

On the basis of a blood test, Mini Nutritional Assessment, food diary and nutritional anamnesis, the nutritionist developed a plan for individualised nutritional care and discussed with the caregivers. If the caregivers seemed unable to increase the energy and/or protein of their diet, daily complementary dietary drinks were recommended to them. The participants were re-examined six months after the baseline interviews to evaluate the effectiveness of the interventions.

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

No Intervention: Control group of nutrition

The control group has the same examinations as the intervention group, they do not get dietary counseling.

Experimental: Intervention group of oral health

After the dental hygienist interview and oral health examination, the caregivers in need were targeted for oral health intervention. The intervention included individualised instructions on either dental hygiene, denture hygiene, cleaning of the oral mucosa or for dry mouth. The participants were re-examined six months after the baseline interviews to evaluate the effectiveness of the interventions.

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

No Intervention: Control group of oral health

The control group has the same examinations as the intervention group, they do not get oral health counseling.

Outcome Measures

Primary Outcome Measures

  1. Nutritional status [Baseline and 6 months and (12 months follow-up visit)]

    Change in MNA scores

  2. Albumin [Baseline and 6 months and (12 months follow-up visit)]

    Change in plasma albumin concentration

  3. Prealbumin [Baseline and 6 months and (12 months follow-up visit)]

    Change in plasma prealbumin concentration

  4. Body mass index (kg/m2) [Baseline and 6 months and (12 months follow-up visit)]

    Change in BMI

  5. Hand grip strength [Baseline and 6 months and (12 months follow-up visit)]

    Change in had grip strength of boot hands

  6. Number and location of teeth [Baseline and 6 months and (12 months follow-up visit)]

    Change in number and location of teeth

  7. Type and location of removable dental prosthesis [Baseline and 6 months and (12 months follow-up visit)]

    Change in type and location of removable dental prosthesis

  8. Oral mucosa [Baseline and 6 months and (12 months follow-up visit)]

    Change in oral mucosa

  9. Condition of teeth [Baseline and 6 months and (12 months follow-up visit)]

    Change in condition of teeth

  10. Presence of plaque [Baseline and 6 months and (12 months follow-up visit)]

    Change in presence of plaque

  11. Gingival bleeding and measurement of periodontal pockets [Baseline and 6 months and (12 months follow-up visit)]

    Change in gingival bleeding and measurement of periodontal pockets

  12. Dental and denture hygiene [Baseline and 6 months and (12 months follow-up visit)]

    Change dental and denture hygiene

  13. Subjective feeling of dry mouth and pain in mouth [Baseline and 6 months and (12 months follow-up visit)]

    Change in subjective feeling of dry mouth and pain in mouth

Secondary Outcome Measures

  1. Activities of Daily Living [Baseline and 6 months and (12 months follow-up visit)]

    Change in Activities of Daily Living (ADL) scores

  2. Instrumental Activities of Daily Living [Baseline and 6 months and (12 months follow-up visit)]

    Change in Instrumental Activities of Daily Living (IADL) scores

  3. Quality of Life (WHOQOL) -bref scores [Baseline and 6 months and (12 months follow-up visit)]

    Change in quality of Life (WHOQOL) -bref scores

  4. Depression [Baseline and 6 months and (12 months follow-up visit)]

    Change in Geriatric Depression Scale (GDS)-15 scores

  5. Cognition [Baseline and 6 months and (12 months follow-up visit)]

    Change in Mini Mental State Examination (MMSE) scores

  6. Sense of coherence [Baseline and 6 months and (12 months follow-up visit)]

    Change in sense of coherence (SOC) scores

  7. Morbidity [Baseline]

    Functional Comorbidity Index (FCI) scores

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • caregivers who have a caregiver´s contract valid on 1 January 2019

  • care recipients living at home

Exclusion Criteria:
  • in terminal care

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Eastern Finland Kuopio Finland FI-70210

Sponsors and Collaborators

  • University of Eastern Finland
  • Kuopio University Hospital

Investigators

  • Study Director: Ursula o Schwab, PhD, Study Principal Inverstigator, professor
  • Principal Investigator: Liisa o Suominen, PhD, Study Principal Inverstigator, professor
  • Principal Investigator: Tarja o Välimäki, PhD, Study Principal Inverstigator, adjuct professor
  • Principal Investigator: Irma o Nykänen, PhD, Study Principal Investigator, adjuct professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Eastern Finland
ClinicalTrials.gov Identifier:
NCT04003493
Other Study ID Numbers:
  • LENTO
First Posted:
Jul 1, 2019
Last Update Posted:
Nov 11, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Eastern Finland
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 11, 2021