Nutrition, Oral HealthNutOrMedNCT02214758
Optimising Nutrition, Oral Health and Medication for Older Home Care Clients (NutOrMed)
A study testing Nutrition and oral health interventions in people with Nutrition, Oral Health, run by University of Eastern Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Oral Health
- What is being tested?
- Nutrition and oral health interventions
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- home care clients
Who cannot join
- under 75 years
About this study
Official title: Optimising Nutrition, Oral Health and Medication for Older Home Care Clients
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.
- Conditions
- Nutrition, Oral Health
- Being tested
- Nutrition and oral health interventions
- Keywords
- Home care clients, nutrition, oral health, medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and oral health interventionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Dietary counseling | Other | Not described Receives: Other: Nutrition and oral health interventions |
| Oral health counseling | Other | Not described Receives: Other: Nutrition and oral health interventions |
| nutrition no counseling | No intervention | Not described |
| oral health no counseling | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nutrition, Oral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irma Nykänen, University of Eastern Finland
- Investigators
- Irma Nykänen, PhD, Principal investigator, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214758
- Sponsor's protocol ID
- RECID84/2012
- Acronym
- NutOrMed
- Status last verified
- Aug 2014
- First submitted
- 4 Aug 2014
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
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 35527353Kaipainen 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 35505290Luukkonen 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 29300435Miettinen 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 29149866Tiihonen 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 28699419Polonen 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Nutrition, Oral Health and Medication for Older Home Care Clients
- ClinicalTrials.gov ID
- NCT02214758
- Acronym / sponsor ID
- NutOrMed / RECID84/2012
- Conditions
- Nutrition, Oral Health
- Keywords
- Home care clients, nutrition, oral health, medication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 12 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dietary counseling | Other | Other: Nutrition and oral health interventions |
| Oral health counseling | Other | Other: Nutrition and oral health interventions |
| nutrition no counseling | No intervention | – |
| oral health no counseling | No intervention | – |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- home care clients
Key exclusion criteria (1 listed)
- under 75 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition and oral health interventionsOn 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. | Other | Dietary counseling, Oral health counseling |
Primary outcome
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
1 secondary outcome
Change from baseline in oral health status on clinical oral health examination and in-home interview at months 6
Time frame: Baseline, Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
- Derived from this study: PubMed 35527353Salmi 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.
- Derived from this study: PubMed 35505290Kaipainen 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.
- Derived from this study: PubMed 29300435Luukkonen 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.
- Derived from this study: PubMed 29149866Miettinen 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.
- Derived from this study: PubMed 28699419Tiihonen 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.
- Derived from this study: PubMed 28448088Polonen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irma Nykänen, PhD principal investigator
University of Eastern Finland
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and oral health interventions in people with Nutrition, Oral Health, run by University of Eastern Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02214758, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2014.