DeliriumFamHelpNCT05321771
Family Caregiver Role in Decreasing Delirium in Older Patients With Fractured Femur Using HELP Principles.
A study testing Family caregiver application of HELP principles in people with Delirium and Femoral Fracture, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The Hospital Elder Life Program (HELP) has been shown to reduce delirium in hospitalized patients. In this study a family caregiver will apply the principles of the HELP program in a structured manner following training by a nurse clinical specialist in geriatrics. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium, Femoral Fracture
- What is being tested?
- Family caregiver application of HELP principles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Dec 2021to 30 Jun 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Males and females aged 65 years and older
- Acute hospitalization in the orthopedic unit for fractured femur post-fall
- Expected or actual surgical intervention for treatment of fracture
- At least one family caregiver involved in supporting the patient during hospitalization
Who cannot join
- Documented conditions that have been clinically active during the previous 6 months: including psychiatric illness; cerebrovascular disease; brain malignancy; alcohol abuse; drug abuse
- Terminal disease
- Delirium
- Inability to assess for delirium due to advanced dementia or sensory deprivation (marked impairment of vision or hearing) or any other condition that limits communication with the patient
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, North, 3109601
Tzvi Dwolatzky, 502061183, t_dwolatzky@rambam.health.gov.il
Orit Meshulam, 972-47772952, o_meshulam@rambam.health.gov.il
About this study
Official title: The Effect of Involving a Family Caregiver in Promoting the Principles of the Hospital Elder Life Program on Decreasing Delirium Among Older Patients Hospitalized in the Orthopedic Unit Following Surgery for Post-fall Femoral Fracture.
The Hospital Elder Life Program (HELP) has been shown to reduce delirium in hospitalized patients. In this study a family caregiver will apply the principles of the HELP program in a structured manner following training by a nurse clinical specialist in geriatrics. The effect of this intervention in decreasing delirium in older patients treated in an acute orthopedic unit for fractured femur following a fall will be evaluated.
Read the detailed description
Approximately 30% of those aged 65 years and over will fall at least once a year. As many as 38% of all older people hospitalized following a fall are admitted with hip fractures and 93% of these will undergo surgical repair of the fracture (Ministry of Health, 2015). Fractured femur is associated with many complications. Delirium (acute confusional state) following surgery is one of the most common of these complications, it often results in adverse outcomes for both patients and caregivers (Tieges et al., 2021), and places great financial burden on the health system. It must be emphasized that delirium can be prevented, and when it occurs should be recognized and treated appropriately. The HELP (Hospital Elder Life Program) is an accepted evidence-based model that has been proven to be effective in reducing delirium at the time of acute hospitalization (Inouye et al., 1999). HELP (which has been implemented at the Rambam Healthcare Campus) is a volunteer-based program using non-pharmacological interventions that include engaging patients in conversation, particularly emphasizing orientation to time and place, encouraging eating and drinking, and assisting with early mobility (Inouye, 2000). The HELP program has been shown to reduce delirium by one-fifth in previous studies (Wang et al., 2020). In this study a family caregiver will apply the principles of the HELP program in a structured manner following training by a nurse clinical specialist in geriatrics. The effect of this intervention in decreasing delirium in older patients treated in an acute orthopedic unit for fractured femur following a fall will be evaluated.
- Conditions
- Delirium, Femoral Fracture
- Being tested
- Family caregiver application of HELP principles
- Keywords
- Elderly, Acute hospitalization, Family caregiver, Hospital Elder Life Program
- Medical subject headings
- Delirium, Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family caregiver application of HELP principlesOther
The family caregiver will apply the principles of the HELP program in a structured manner following training by a nurse clinical specialist in geriatrics. These principles include engaging patients in conversation, particularly emphasizing orientation to time and place, encouraging eating and drinking, and assisting with early mobility.
| Study group | Role | What they receive |
|---|---|---|
| Family caregiver application of HELP principles | Experimental | The family caregiver will apply the principles of the HELP program in a structured manner following training by a nurse clinical specialist in geriatrics. The patient will be assessed daily by means of the Confusion Assessment Method (CAM) and the 4 'A's test (Arousal, Attention, Abbreviated Mental Test - 4, Acute change) (4AT) to determine delirium incidence. Receives: Other: Family caregiver application of HELP principles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium
The incidence of delirium will be determined according to the results of patient assessment by means of the CAM and 4AT instruments.
Measured: From date of signing informed consent until the date of first documented diagnosis of delirium or hospital discharge, whichever came first, assessed up to a maximum of 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start2 Dec 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm single center prospective interventional study.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tzvi Dwolatzky, Rambam Health Care Campus
- Investigators
- Galit Geller Bigelman, MA, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321771
- Sponsor's protocol ID
- 0508-21-RMB
- Acronym
- FamHelp
- Status last verified
- May 2024
- First submitted
- 14 Mar 2022
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available to other researchers on request
Publications
Tieges Z, Maclullich AMJ, Anand A, Brookes C, Cassarino M, O'connor M, Ryan D, Saller T, Arora RC, Chang Y, Agarwal K, Taffet G, Quinn T, Shenkin SD, Galvin R. Diagnostic accuracy of the 4AT for delirium detection in older adults: systematic review and meta-analysis. Age Ageing. 2021 May 5;50(3):733-743. doi: 10.1093/ageing/afaa224.
PubMed 33951145Inouye SK, Bogardus ST Jr, Charpentier PA, Leo-Summers L, Acampora D, Holford TR, Cooney LM Jr. A multicomponent intervention to prevent delirium in hospitalized older patients. N Engl J Med. 1999 Mar 4;340(9):669-76. doi: 10.1056/NEJM199903043400901.
PubMed 10053175Inouye SK, Bogardus ST Jr, Baker DI, Leo-Summers L, Cooney LM Jr. The Hospital Elder Life Program: a model of care to prevent cognitive and functional decline in older hospitalized patients. Hospital Elder Life Program. J Am Geriatr Soc. 2000 Dec;48(12):1697-706. doi: 10.1111/j.1532-5415.2000.tb03885.x.
PubMed 11129764Wang YY, Yue JR, Xie DM, Carter P, Li QL, Gartaganis SL, Chen J, Inouye SK. Effect of the Tailored, Family-Involved Hospital Elder Life Program on Postoperative Delirium and Function in Older Adults: A Randomized Clinical Trial. JAMA Intern Med. 2020 Jan 1;180(1):17-25. doi: 10.1001/jamainternmed.2019.4446.
PubMed 31633738
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Involving a Family Caregiver in Promoting the Principles of the Hospital Elder Life Program on Decreasing Delirium Among Older Patients Hospitalized in the Orthopedic Unit Following Surgery for Post-fall Femoral Fracture.
- ClinicalTrials.gov ID
- NCT05321771
- Acronym / sponsor ID
- FamHelp / 0508-21-RMB
- Conditions
- Delirium, Femoral Fracture
- Keywords
- Elderly, Acute hospitalization, Family caregiver, Hospital Elder Life Program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 11 Apr 2022 (actual)
- 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 Hospital Elder Life Program (HELP) has been shown to reduce delirium in hospitalized patients. In this study a family caregiver will apply the principles of the HELP program in a structured manner following training by a nurse clinical specialist in geriatrics. The effect of this intervention in decreasing delirium in older patients treated in an acute orthopedic unit for fractured femur following a fall will be evaluated.
Detailed description
Approximately 30% of those aged 65 years and over will fall at least once a year. As many as 38% of all older people hospitalized following a fall are admitted with hip fractures and 93% of these will undergo surgical repair of the fracture (Ministry of Health, 2015). Fractured femur is associated with many complications. Delirium (acute confusional state) following surgery is one of the most common of these complications, it often results in adverse outcomes for both patients and caregivers (Tieges et al., 2021), and places great financial burden on the health system. It must be emphasized that delirium can be prevented, and when it occurs should be recognized and treated appropriately. The HELP (Hospital Elder Life Program) is an accepted evidence-based model that has been proven to be effective in reducing delirium at the time of acute hospitalization (Inouye et al., 1999). HELP (which has been implemented at the Rambam Healthcare Campus) is a volunteer-based program using non-pharmacological interventions that include engaging patients in conversation, particularly emphasizing orientation to time and place, encouraging eating and drinking, and assisting with early mobility (Inouye, 2000). The HELP program has been shown to reduce delirium by one-fifth in previous studies (Wang et al., 2020). In this study a family caregiver will apply the principles of the HELP program in a structured manner following training by a nurse clinical specialist in geriatrics. The effect of this intervention in decreasing delirium in older patients treated in an acute orthopedic unit for fractured femur following a fall will be evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm single center prospective interventional study.
| Arm | Type | Receives |
|---|---|---|
| Family caregiver application of HELP principles | Experimental | Other: Family caregiver application of HELP principlesThe family caregiver will apply the principles of the HELP program in a structured manner following training by a nurse clinical specialist in geriatrics. The patient will be assessed daily by means of the Confusion Assessment Method (CAM) and the 4 'A's test (Arousal, Attention, Abbreviated Mental Test - 4, Acute change) (4AT) to determine delirium incidence. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Males and females aged 65 years and older
- Acute hospitalization in the orthopedic unit for fractured femur post-fall
- Expected or actual surgical intervention for treatment of fracture
- At least one family caregiver involved in supporting the patient during hospitalization
Key exclusion criteria (4 listed)
- Documented conditions that have been clinically active during the previous 6 months: including psychiatric illness; cerebrovascular disease; brain malignancy; alcohol abuse; drug abuse
- Terminal disease
- Delirium
- Inability to assess for delirium due to advanced dementia or sensory deprivation (marked impairment of vision or hearing) or any other condition that limits communication with the patient
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 |
|---|---|---|
| Family caregiver application of HELP principlesThe family caregiver will apply the principles of the HELP program in a structured manner following training by a nurse clinical specialist in geriatrics. These principles include engaging patients in conversation, particularly emphasizing orientation to time and place, encouraging eating and drinking, and assisting with early mobility. | Other | Family caregiver application of HELP principles |
Primary outcome
Incidence of delirium
Time frame: From date of signing informed consent until the date of first documented diagnosis of delirium or hospital discharge, whichever came first, assessed up to a maximum of 100 days
The incidence of delirium will be determined according to the results of patient assessment by means of the CAM and 4AT instruments.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Results publication: PubMed 33951145Tieges Z, Maclullich AMJ, Anand A, Brookes C, Cassarino M, O'connor M, Ryan D, Saller T, Arora RC, Chang Y, Agarwal K, Taffet G, Quinn T, Shenkin SD, Galvin R. Diagnostic accuracy of the 4AT for delirium detection in older adults: systematic review and meta-analysis. Age Ageing. 2021 May 5;50(3):733-743. doi: 10.1093/ageing/afaa224.
- Results publication: PubMed 10053175Inouye SK, Bogardus ST Jr, Charpentier PA, Leo-Summers L, Acampora D, Holford TR, Cooney LM Jr. A multicomponent intervention to prevent delirium in hospitalized older patients. N Engl J Med. 1999 Mar 4;340(9):669-76. doi: 10.1056/NEJM199903043400901.
- Results publication: PubMed 11129764Inouye SK, Bogardus ST Jr, Baker DI, Leo-Summers L, Cooney LM Jr. The Hospital Elder Life Program: a model of care to prevent cognitive and functional decline in older hospitalized patients. Hospital Elder Life Program. J Am Geriatr Soc. 2000 Dec;48(12):1697-706. doi: 10.1111/j.1532-5415.2000.tb03885.x.
- Results publication: PubMed 31633738Wang YY, Yue JR, Xie DM, Carter P, Li QL, Gartaganis SL, Chen J, Inouye SK. Effect of the Tailored, Family-Involved Hospital Elder Life Program on Postoperative Delirium and Function in Older Adults: A Randomized Clinical Trial. JAMA Intern Med. 2020 Jan 1;180(1):17-25. doi: 10.1001/jamainternmed.2019.4446.
- Individual participant dataSharing planned: No. Data will be available to other researchers on request
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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.
Galit Geller Bigelman, MA principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family caregiver application of HELP principles in people with Delirium and Femoral Fracture, run by Rambam Health Care Campus at 1 site in Israel.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Galit Geller Bigelman, MA (+97247771192, GG_Bigelman@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delirium (time frame: From date of signing informed consent until the date of first documented diagnosis of delirium or hospital discharge, whichever came first, assessed up to a maximum of 100 days). 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 NCT05321771, which also lists 4 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 7 May 2024.