Audio-Recorded Messages Delivered Via iPad to Prevent Delirium in Hip Fracture Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorSengkang General Hospital

About this trial

The goal of this pilot clinical trial is to learn if personalized audio-recorded reorientation messages can be successfully implemented in general hospital wards for elderly patients after hip fracture surgery. It will also explore whether this intervention might help prevent confusion (delirium) after surgery. The main questions it aims to answer are:

* Can the intervention be successfully delivered by nursing staff in a busy orthopedic ward? * How many eligible patients can be recruited and retained in the study? * Do patients tolerate listening to the personalized audio messages without problems? * Does listening to personalized audio messages show any early signs of reducing confusion after surgery?

Researchers will compare patients who receive personalized audio messages to those who receive usual care to see if the intervention is feasible to implement and whether it shows promise for preventing delirium.

Participants will:

* Listen to 2-minute personalized audio-recorded reorientation messages played through an iPad and headphones three times daily for the first 3 days after surgery * Have their orientation and mental status checked daily for three times by nursing staff * Continue with all their regular medical care and treatments * Be monitored until discharge from the study wards.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Older adults aged 60 years and above

Undergoing hip fracture repair surgery

No history of cognitive impairment as assessed by Abbreviated Mental Test (AMT)

Able to understand to any of the basic languages of Singapore (English, Malay, Mandarin, Tamil)

Disqualifiers

Patients not admitted directly to orthopaedic (study) wards post-operation (such as those requiring post-operative high-dependency unit care)

Patients managed conservatively without surgical intervention.

Patients admitted for periprosthetic hip fracture repairs

Patients who are deaf and mute

Trial design

Design model

Parallel

Treatments tested in this trial

  • Audio-Recorded Reorientation Intervention

    Behavioral

    Participants in this arm receive personalized audio-recorded reorientation messages delivered three times daily during the first three post-operative days. Each message lasts approximately 2 minutes and contains personalized information including the current location, date and time, and encouraging messages. Messages are delivered via iPad and headphones by nursing staff during routine care. Audio messages are available in English, Mandarin, Malay, and Tamil to accommodate patient language preferences. Participants also receive all standard post-operative care and treatments.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Audio-Recorded Reorientation InterventionExperimental treatment 1 intervention
Group B: Standard Care ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Protocol Adherence Rate

Percentage of planned audio-recorded reorientation sessions successfully delivered by the nurses across the first 3-day intervention period. Target adherence rate ≥95% to demonstrate intervention feasibility.

Time frame
Postoperative day 1 to postoperative day 3
2

Recruitment Feasibility

Recruitment feasibility measured by screening-to-enrollment rate, calculated as: (1) percentage of screened patients meeting eligibility criteria, and (2) percentage of eligible patients providing informed consent. These rates will be tracked throughout the study period to assess the feasibility of recruiting the target population for a future definitive trial. Target enrollment rate of ≥80% of eligible patients will indicate feasibility.

Time frame
From enrollment to end of study participation (up to 2 weeks)
3

Study Retention Rate

Percentage of enrolled participants who completed the study protocol without withdrawal, calculated as number completing study divided by total enrolled. Target retention rate ≥90% to demonstrate intervention feasibility.

Time frame
From enrollment to end of study participation (up to 2 weeks)
4

Intervention Tolerance Rate

Completion of each audio-recorded reorientation session without early discontinuation or adverse reactions, assessed during each of the 9 planned sessions per participant. Target adherence rate ≥95% to demonstrate intervention feasibility.

Time frame
Postoperative Day 1 to Postoperative Day 3

Secondary outcomes

1

Number of participants with delirium as assessed by 4AT (4 'A's Test) screening tool

Delirium will be assessed using the 4AT (4 'A's Test), a validated 4-item screening instrument that evaluates alertness, attention (months backwards), acute change or fluctuating course, and AMT4 (age, date of birth, place, current year). The 4AT score ranges from 0-12, with scores ≥4 indicating possible delirium and scores ≥1 suggesting cognitive impairment. Delirium incidence will be reported as the number and percentage of participants who score ≥4 on the 4AT during their study participation period.

Time frame
From postoperative day 1 to end of study participation (up to 2 weeks)
2

Length of stay in study ward measured in days

Length of stay will be measured as the total number of days from admission to the pilot ward until discharge from the pilot ward (either to home, transfer to another ward, or transfer to community hospital). This measure captures only the time spent specifically in the study/pilot ward and does not include any subsequent stays in other wards or facilities. Length of stay will be calculated in whole days and reported as mean, median, and range.

Time frame
From admission to pilot ward until discharge/transfer from pilot ward (up to 2 weeks)
3

Number of participants actively participating in prescribed physiotherapy and occupational therapy sessions

Allied health participation will be measured as the number and percentage of participants who actively engage in their prescribed physiotherapy (PT) and occupational therapy (OT) sessions during their stay in the pilot ward. Participation will be defined as attending and actively engaging in therapy sessions as documented by the treating therapists. Since all hip fracture patients receive standard PT/OT orders, this outcome measures engagement rather than referral rates. Data will be collected through therapy documentation review.

Time frame
From postoperative day 1 to postoperative day 3
4

Cumulative analgesic consumption

Analgesic consumption will be measured as the total cumulative dose of commonly prescribed analgesics (morphine, paracetamol, and oxycodone) consumed by participants during post-operative days 1 to 3. All doses will be recorded in their respective units (morphine in mg, paracetamol in mg, oxycodone in mg) from medication administration records. This outcome assesses whether improved orientation and medication compliance messaging through the audio-recorded intervention affects analgesic usage patterns. Data will include both scheduled and PRN (as needed) doses administered.

Time frame
From postoperative day 1 to postoperative day 3

Other outcomes

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