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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Irma Nykänen, University of Eastern Finland
ClinicalTrials.gov Identifier:
NCT02214758
First received: August 4, 2014
Last updated: August 8, 2014
Last verified: August 2014
  Purpose
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.

Condition Intervention
Nutrition, Oral Health
Other: Nutrition and oral health interventions

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Optimising Nutrition, Oral Health and Medication for Older Home Care Clients

Resource links provided by NLM:


Further study details as provided by Irma Nykänen, University of Eastern Finland:

Primary Outcome Measures:
  • Change from baseline in nutritional status on the Mini Nutritional Assessment (MNA) test and s-albumin level at months 6 [ Time Frame: Baseline, Month 6 ]
    Using MNA test and s-albumin level test


Secondary Outcome Measures:
  • Change from baseline in oral health status on clinical oral health examination and in-home interview at months 6 [ Time Frame: Baseline, Month 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


Other Outcome Measures:
  • The agreement between medication in-home interview and EMR in baseline [ Time Frame: 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


Enrollment: 300
Study Start Date: November 2012
Study Completion Date: June 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Dietary counseling Other: Nutrition 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.
Oral health counseling Other: Nutrition 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.
No Intervention: nutrition no counseling
No Intervention: oral health no counseling

  Eligibility

Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • home care clients

Exclusion Criteria:

  • under 75 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02214758

Sponsors and Collaborators
University of Eastern Finland
Investigators
Principal Investigator: Irma Nykänen, PhD University of Eastern Finland
  More Information

Responsible Party: Irma Nykänen, PhD, University of Eastern Finland
ClinicalTrials.gov Identifier: NCT02214758     History of Changes
Other Study ID Numbers: RECID84/2012
Study First Received: August 4, 2014
Last Updated: August 8, 2014

Keywords provided by Irma Nykänen, University of Eastern Finland:
Home care clients, nutrition, oral health, medication

ClinicalTrials.gov processed this record on May 25, 2017