Preventing the onset of delirium in the elderly

JRCT ID: jRCT1010240013

Registered date:23/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Stroke
• Date of first enrollment: 23/05/2024
• Target sample size: 60
• Study type: Interventional

Intervention(s)

In order to provide a uniform intervention method for constipation to the study subjects, in the first phase, the duration will be two to three weeks and the intervention collaborators will provide educational interventions to the intervention collaborators by this researcher. In the second phase, the researcher will select subjects and conduct a pre-trial using a constipation care protocol so that the intervention collaborators can provide a uniform intervention for the subjects for a period of two weeks. During the trial period, the intervention will be evaluated every 3-5 days, and any differences in the intervention will be explained to the intervention partners and modified. After it is determined that there are few differences between intervention partners, the intervention will be initiated in the study subjects.
The intervention will be carried out for a total of 8 days, including the first 8 days of the intervention, to investigate whether the intervention for constipation relieves constipation in the subjects and whether they develop delirium. The study will be completed as soon as a sufficient sample size (approximately 60 subjects in the intervention group) is secured. Evaluation during the intervention will be carried out every week from the start of the intervention, and revisions will be made on a case-by-case basis.
(1) Educational intervention for intervention collaborators
The content of the educational intervention for intervention partners in the first phase includes screening methods using the CAM delirium rating scale and constipation intervention methods (defaecation care, constipation care protocol). The contents of defecation care include: understanding the characteristics of defecation and constipation in the elderly (understanding defecation rhythm, early detection of abnormalities associated with constipation, side effects of medication), lifestyle support methods to re-establish defecation rhythm (diet, fluid intake, activity level, lifestyle rhythm, stress, etc.), support for defecation function (blood circulation promotion in the abdomen and lumbar region, defecation The method of educational intervention is based on the content of the paper. The method of educational intervention is to describe the content on paper in a lecture format, and after the course, the level of understanding is assessed using a test method, and questions are asked and whether or not nursing intervention is possible in clinical practice. Based on the content of the interviews, the method was modified so that the nursing intervention could be carried out with as little difference as possible between the collaborators, and the modifications were described and explained again on paper.
In this study, delirium assessment of the subjects was conducted using CAM. A screening evaluation chart using the CAM will be prepared in advance, and the method of use will be explained to the intervention collaborators, who will be asked to evaluate the subjects. To minimise differences in screening results, training will be conducted using case examples prior to the intervention, and the evaluation time and frequency using CAM will basically be twice a day, from 13 to 17:00 during the day shift and from 19 to 23:00 during the night shift. Assessment is also carried out when the onset of delirium is suspected by the subject's speech or behaviour during each work period. The evaluation period is from the first day to the eighth day of the intervention.
(2) Pre-trial using a constipation care protocol
In the second phase, a "constipation care protocol" developed by the researchers was used so that the intervention collaborators could provide uniform care to the subjects. A defaecation diary will be kept for eight days, and pharmacological interventions (laxatives, suppositories, enemas) will be given using the care protocol if the subject is constipated during this period.
As a non-pharmacological approach is important as an intervention for constipation, in this study, the subjects will initially receive the required fluid intake and lactic acid bacteria drinks containing probiotics, and if they are still constipated, a pharmacological intervention using laxatives, suppositories or enemas will be administered. Although this pharmacological intervention is invasive for the subject, it is a common method in the treatment of constipation, with few side effects and low risk to the subject.

Outcome(s)

• Primary Outcome: Japanese version of Constipation assessment scale Ver. 2, ConstipationQOL15 revised QOL assessment index for constipation, Confusion Assessment Method

Key inclusion & exclusion criteria

• Age minimum: >= 70age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients aged 70 years or older within 3 days of admission to hospital who fulfil the following conditions.
1) Patients admitted with acute stroke and receiving medical treatment.
2) To avoid a mixture of stroke and delirium symptoms, the level of consciousness at admission should be in the range of 11-15 on the GCS (E4V1-5M6).
(E4V1~5M6) on admission to avoid a mixture of stroke and delirium.
3) The patient is allowed to eat by a doctor and is able to take food orally. However, at Hospital A, the speech-language pathologist conducts a feeding and swallowing assessment and is entrusted with the decision on oral intake, so the decision should be made by the speech-language pathologist.
4) The patient and his/her family understand this study and are capable of making a decision to consent to the provision of information.

Exclude criteria

Surgical treatment and catheterisation are not included.
To avoid mixing stroke and delirium symptoms, the level of consciousness on admission should be in the range of 11-15 (E4V1-5M6) on the GCS.
(E4V1~5M6) on admission to avoid a mixture of stroke and delirium. Otherwise, patients are excluded.
Patients with difficulty in communication and assessment of symptoms due to higher brain dysfunction are excluded.
Patients with delirium on admission are excluded.
Patients with a diagnosis of dementia prior to admission are excluded because they are at high risk of developing delirium and are difficult to distinguish from behavioural and psychological symptoms.

Related Information

• Primary Sponsor: Takahashi Norihito