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DRIE 2 (Dehydration Recognition In our Elders ? Re-test)

Testing of a simple tool for diagnosis of water-loss dehydration: a diagnostic accuracy study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN58315094
Enrollment
200
Registered
2014-05-21
Start date
2014-05-01
Completion date
Unknown
Last updated
2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Water-loss dehydration, signified by raised serum osmolality (>300 mOsm/kg). Signs and Symptoms Lack of water

Interventions

The trialists will test for water-loss dehydration (through blood osmolality) and also carry out the assessments needed for the decision trees, as well as collecting health and demographic information

Sponsors

University of East Anglia (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. People aged 65+ living in residential care (care homes, nursing homes and mixed homes) in Norfolk or Suffolk (UK) 2. Participants will be included regardless of their capacity to provide informed consent, although the study is designed to protect all participants and include them only if they find the research acceptable 3. Inclusion of those with dementia was strongly encouraged by the NIHR interview panel that awarded the funding for this research, as those with dementia are at greatly increased risk of dehydration, so it is vital that the tool developed is applicable to those with dementia as well as those without. This decision has been strongly supported by care home managers and staff before and during the course of the original DRIE study. We will only include adults who can provide their own informed and signed consent OR whose consultee has provided signed consent that they believe that the resident would have consented if they were able to make the decision themselves 4. The trialists do not plan to stratify inclusion by age group (as most of those living in residential care will be either physically or mentally frail, all will be at some increased risk of dehydration), or by gender (although the samples are likely to be weighted towards women, as more care home residents are women). While they are aiming for a representative sample of care home residents, they will not exclude any interested participants on this basis. The sample of care home residents is likely to be rather less frail than the average resident as those with better physical and cognitive capacities are more likely to feel able to participate, but they will collect a small amount of data on all residents in the homes we work in to assess the representativeness of the study sample.

Exclusion criteria

Exclusion criteria: 1. Those who the care home manager is aware have been diagnosed with renal failure or heart failure, as fluid physiology changes with these conditions (and fluid retention is more likely) 2. Those in receipt of palliative care, or with illnesses that suggest they are unlikely to survive for at least 3 months will not be recruited 3. Who are unable to provide their own consent, and are known to be frightened of, or upset by, needles or blood tests as we will assume that the process of the interview and blood sample will be upsetting to them

Design outcomes

Primary

MeasureTime frame
Whether the simple decision tree usefully predicts dehydration in care home residents.

Secondary

MeasureTime frame
1. Acceptability and invasiveness of the individual assessments to older people living in residential care 2. The relationship between nutritional status (assessed by change in weight over the past 6 months, body mass index, Mini Nutritional Assessment, Malnutrition Universal Screening Tool, haemoglobin) and hydration status in care home residents 3. Assessing some additional promising clinical and/or physical signs or questions (such as assessing foot skin turgor, dry lips, asking participants whether they feel out of sorts, and whether they drink as much as they need to stay healthy, completing the mini-mental state exam, observing whether participants taste their drink immediately and recording their Barthel score and number of medications prescribed) so that if the current decision tree does not prove useful we have a strong evidence base (from 200 participants in the DRIE study, and a further 200 participants in DRIE 2) to allow development of a better decision tree.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026