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IRCT20180910040995N1 IRCT 2019-02-07 University of social welfare and rehabilitation sciences Effect of HELP Model on Prevention of Delirium Effectiveness of HELP ( Hospitalized Elder Life program) care model to prevent delirium in hospitalized older patients 2018-10-07 anticipated 110 Complete https://irct.ir/trial/33830 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Since the delirium risk (moderate and severe) as a confounding variable can lead to imbalance in the intervention and control groups, the Allocation Stratified Block Random method is used in this study. Initially, a sample of 110 (in each group of 55) predicted for this study, based on the risk of delirium, is divided into two groups of moderate (55) and severe (55), then for each group with moderate risk and severe 14 blocks of 4 (2: 2 ratio, each with two controls and two persons) are considered. Determine the number of blocks and layout of individuals in each block using a random number table and determined by someone other than the researcher and those who participate in the sampling. The researcher will be informed by telephone by contacting him about how the block is arranged, Blinding description: The researcher uses the following methods to reduce contact between patients in both control and intervention groups. 1. Considering that the hospital wards of the sampling site have 4-bed rooms, it is possible to observe and learn the interventions by patients or their carers in the control group so only one patient's room is selected for participation in the study. In case of non-limitation in time for sampling, the researcher can choose a patient to participate in the study in order to prevent the association of patients in the control and intervention groups from each ward. 2. In this study patients will be evaluated and interventions will be conducted by different people. Teaching people who take initial and daily evaluations of patients and those who are selected for interventions is conducted in separate educational sessions. N/A delirium. Intervention 1: Intervention group: Interventions are provided by nursing students in the form of a care program for elderly patients admitted to the hospital. Interventions include the following: 1.Develop & update individualized care plans. 2.Orientation/Daily Visitor: All patients are enrolled in the Daily Visitor/ Orientation Program. This program is done by Orientation board that a board that is written on with names of care team members and daily schedule) 3.Therapeutic Activities Program: All patients are enrolled in the Therapeutic Activities Program. This program is included activities e.g., discussion of current events, and word games.4. Sleep Enhancement: Patients who have difficulty falling asleep or sleep poorly at home or in the hospital are enrolled in The Sleep Protocol. This Protocol is included Nonpharmacologic Interventions e.g., to drink at bedtime, warm milk drink, relaxation recordings or music, and back massage.To use Unit-wide noise reduction strategies (e.g., quiet hallways) and schedule adjustments to allow uninterrupted sleep (e.g., rescheduling of medications and procedures). 5.Early Mobilization Program: All patients are enrolled in the Early Mobilization Program.This Program is Ambulation or active range-of-motion exercises three times daily.6. Vision Protocol: Patients are enrolled if near vision in both eyes that Visual aids is used e.g., glasses or magnifying lenses for them 7.Hearing Protocol: Patients are enrolled if they hear <3 whispers from each ear on the Whisper Test or are unable to hear fingers lightly rubbed on the Finger Rub Test. There are used for them Portable amplifying devices and special communication techniques 8.Feeding Assistance Program: Patients who rate their appetite as “poor” are enrolled into the Feeding Assistance Protocol. Level of feeding assistance is also determined by physical and cognitive impairment. This program is included Feeding assistance and encouragement patients during meals.9. Fluid Repletion is Early recognition of dehydration and oral volume repletion, i.e., encouragement of oral intake of fluids. Intervention 2: Control group: Patients in the control group are receiving routine cares in hospital. Usual care consisted of standard hospital care provided by physicians, nurses, and support staff (eg, dietitians, physical therapists) on hospital. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Afsaneh Kogaie Bidgoli
kodakyar Ave., daneshjo Blvd.,Evin,Tehran
Tehran Iran (Islamic Republic of) 8741736346 +98 31 5472 5963 Kojaiibidgoli@yahoo.com University of social welfare and rehabilitation sciences scientific Afsaneh Kogaie Bidgoli
5th of Qotb –e Ravandi Blvd.Kashan.
Kashan Iran (Islamic Republic of) 8741736346 +98 31 5472 5963 kojaiibidgoli@yahoo.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Age 70 years and older Patients admitted to the internal wards At least one risk factor for delirium at admission (visual impairment, hearing impairment, cognitive impairment , sleep problem, Mobilization impairment, and Dehydration The willingness to participate in the study by the patient and his care Able to communicate verbally Able to communicate in writing in Nonverbal patients Absence of delirium at admission 70 years no limit Both F05 Delirium due to known physiological condition Prevention N/A Intervention group: Interventions are provided by nursing students in the form of a care program for elderly patients admitted to the hospital. Interventions include the following: 1.Develop & update individualized care plans. 2.Orientation/Daily Visitor: All patients are enrolled in the Daily Visitor/ Orientation Program. This program is done by Orientation board that a board that is written on with names of care team members and daily schedule) 3.Therapeutic Activities Program: All patients are enrolled in the Therapeutic Activities Program. This program is included activities e.g., discussion of current events, and word games.4. Sleep Enhancement: Patients who have difficulty falling asleep or sleep poorly at home or in the hospital are enrolled in The Sleep Protocol. This Protocol is included Nonpharmacologic Interventions e.g., to drink at bedtime, warm milk drink, relaxation recordings or music, and back massage.To use Unit-wide noise reduction strategies (e.g., quiet hallways) and schedule adjustments to allow uninterrupted sleep (e.g., rescheduling of medications and procedures). 5.Early Mobilization Program: All patients are enrolled in the Early Mobilization Program.This Program is Ambulation or active range-of-motion exercises three times daily.6. Vision Protocol: Patients are enrolled if near vision in both eyes that Visual aids is used e.g., glasses or magnifying lenses for them 7.Hearing Protocol: Patients are enrolled if they hear <3 whispers from each ear on the Whisper Test or are unable to hear fingers lightly rubbed on the Finger Rub Test. There are used for them Portable amplifying devices and special communication techniques 8.Feeding Assistance Program: Patients who rate their appetite as “poor” are enrolled into the Feeding Assistance Protocol. Level of feeding assistance is also determined by physical and cognitive impairment. This program is included Feeding assistance and encouragement patients during meals.9. Fluid Repletion is Early recognition of dehydration and oral volume repletion, i.e., encouragement of oral intake of fluids Control group: Patients in the control group are receiving routine cares in hospital. Usual care consisted of standard hospital care provided by physicians, nurses, and support staff (eg, dietitians, physical therapists) on hospital. Delirium incidence according to CAM tool. Timepoint: Assessment of Delirium is done from patient's admission to the hospital and then every day until his discharge. Method of measurement: Confusion Assessment Method tool. Score of Activity daily living abilities. Timepoint: Assessment of Activity daily living ability is done at the time of the patient's admission to the hospital (before the intervention) and then the discharge time. Method of measurement: ADL-Barthel tool. Level of fraility. Timepoint: Assessment of frailty is done at the time of the patient's admission to the hospital (before the intervention) and then the discharge time. Method of measurement: Clinical Frailty Index. Number of cases of falling during the hosptalization. Timepoint: The number of falls is checked during days of hospitalization. Method of measurement: documentation survey. Use of anti psychotics drugs or their dose. Timepoint: use of anti psychotics drugs or their dose are checked during days of hospitalization. Method of measurement: documentation survey. Number of readmission after discharge of hospital. Timepoint: Number of readmission is checked 3 month after discharge of hospital. Method of measurement: telephone follow. University of social welfare and rehabilitation sciences Approved 2018-02-26 ethics committee of university of Social Welfare and Rehabilitation Sciences kodakyar Ave., daneshjo Blvd.,Evin Tehran Tehran Iran (Islamic Republic of)