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CompletedNCT02214758NutOrMedUpdated Aug 12, 2014

Optimising Nutrition, Oral Health and Medication for Older Home Care Clients (NutOrMed)

An interventional study of Nutrition and oral health interventions in Nutrition, Oral Health, sponsored by University of Eastern Finland. Completed. Open to participants aged 75 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-12.

Sponsored by University of Eastern Finland · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
75 Years and older
Sex
All
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Study summary

The aim of the study is to evaluate the impact of six month long nutritional and oral health intervention on nutritional status, oral health, functional performance and hospital admission/costs on older persons using home care services. Additionally, participants are interviewed at home regarding their drugs use and this information will be compared with medication information in electronic patient records.

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Conditions studied

  • Nutrition, Oral Health

Keywords

  • Home care clients, nutrition, oral health, medication
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In context

Lead sponsor

University of Eastern Finland is the lead sponsor of 51 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
75 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • home care clients

Exclusion criteria

Exclusion Criteria:

  • under 75 years
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • Other
    Dietary counseling

    Other: Nutrition and oral health interventions

  • Other
    Oral health counseling

    Other: Nutrition and oral health interventions

  • No intervention
    nutrition no counseling
  • No intervention
    oral health no counseling

Interventions

  • OtherNutrition and oral health interventions

    On the basis of a blood test, Mini Nutritional Assessment, and nutritional anamnesis, the nutritionist developed a plan for individualised nutritional care and discussed with the participant and her/his nurse or family members. If the participants seemed unable to increase the energy and/or protein of their diet, daily complementary dietary drinks were recommended to them. After the dental hygienist interview and oral health examination, the participants 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. Both the intervention and control groups had the same examinations as with the exception of the nutritional and oral health intervention.

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What researchers measure

Primary outcomes

  1. Change from baseline in nutritional status on the Mini Nutritional Assessment (MNA) test and s-albumin level at months 6

    Using MNA test and s-albumin level test

    Time frame: Baseline, Month 6

Secondary outcomes

  1. Change from baseline in oral health status on clinical oral health examination and in-home interview at months 6

    Clinical oral health examination included type and location of removable dental prosthesis, examination of the oral mucosa, number and location of teeth, condition of teeth, presence of plaque, gingival bleeding and measurement of periodontal pockets. In-home interview included questions about dental and denture hygiene, a subjective feeling of dry mouth and pain in mouth

    Time frame: Baseline, Month 6

Other outcomes

  1. The agreement between medication in-home interview and EMR in baseline

    A pharmacist recorded each prescription and non-prescription medication and complementary and alternative medicine supplements used regularly, as-needed within a week or in the past on the basis of the interview, medication lists, packages and prescriptions at the baseline. All medications were encoded using the ATC (Anatomic Therapeutic Chemical) classification (WHO). The medication list from the locally used electronic medical record (EMR) was gathered from the same day than in-home interview

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Salmi A, Komulainen K, Nihtila A, Tiihonen M, Nykanen I, Hartikainen S, Suominen AL. Eating problems among old home care clients. Clin Exp Dent Res. 2022 Aug;8(4):959-968. doi: 10.1002/cre2.585. Epub 2022 May 8. PubMed 35527353 ↗
  • Kaipainen T, Hartikainen S, Tiihonen M, Nykanen I. Effect of individually tailored nutritional counselling on protein and energy intake among older people receiving home care at risk of or having malnutrition: a non-randomised intervention study. BMC Geriatr. 2022 May 4;22(1):391. doi: 10.1186/s12877-022-03088-2. PubMed 35505290 ↗
  • Luukkonen A, Tiihonen M, Rissanen T, Hartikainen S, Nykanen I. Orthostatic Hypotension and Associated Factors among Home Care Clients Aged 75 Years or Older - A Population-Based Study. J Nutr Health Aging. 2018;22(1):154-158. doi: 10.1007/s12603-017-0953-9. PubMed 29300435 ↗
  • Miettinen M, Tiihonen M, Hartikainen S, Nykanen I. Prevalence and risk factors of frailty among home care clients. BMC Geriatr. 2017 Nov 17;17(1):266. doi: 10.1186/s12877-017-0660-8. PubMed 29149866 ↗
  • Tiihonen M, Hartikainen S, Nykanen I. Chair rise capacity and associated factors in older home-care clients. Scand J Public Health. 2018 Nov;46(7):699-703. doi: 10.1177/1403494817718072. Epub 2017 Jul 12. PubMed 28699419 ↗
  • Polonen S, Tiihonen M, Hartikainen S, Nykanen I. Individually Tailored Dietary Counseling among Old Home Care Clients - Effects on Nutritional Status. J Nutr Health Aging. 2017;21(5):567-572. doi: 10.1007/s12603-016-0815-x. PubMed 28448088 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02214758
Lead sponsor
University of Eastern Finland
Responsible party
Irma Nykänen (PhD, University of Eastern Finland) — Principal investigator
First posted
Aug 12, 2014
Start date
Nov 2012
Primary completion
May 2013
Completion
Jun 2014
Last update
Aug 12, 2014

Study contacts

Irma Nykänen, PhD
principal investigator · University of Eastern Finland

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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