Albert Health App PEG Study

NCT06772285 | Not Yet Recruiting

• 1 other identifier: 2024GAS132
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Test an existing digital health app, called Albert Health, designed to support patients with a newly inserted feeding tube to use and manage their tube care, in a feasibility study. The feasibility study will evaluate the acceptability, usability and accessibility of the app in preparation for a randomised controlled trial.

Conditions

Feeding Tube Complication

Keywords

Digital health app; Management; PEG; Feeding tube; Insertion; Albert Health; PEG insertion

Outcome Measures

Primary Outcomes (11)

• Evaluate the acceptability of the app intervention to users

  Evaluate the acceptability of the app intervention to users ; interviews, MARS day 14 and 28

  Day 14 and 28

• Evaluate the useability and interaction with the app by users

  Evaluate the useability and interaction with the app by users ; interviews, internal app measures

  18 months

• Evaluate the accessibility of the app to users

  Evaluate the accessibility of the app to users ; interviews

  18 months

• Evaluate the accessibility of the app to users

  Evaluate the accessibility of the app to users ; satisfaction scores (SUS subcale)

  18 months

• Evaluate the accessibility of the app to users

  Evaluate the accessibility of the app to users ; MAUQ-E subscales

  18 months

• Evaluate the useability and interaction with the app by users

  Evaluate the useability and interaction with the app by users ; System Usability Scale SUS

  Day 21

• Evaluate the useability and interaction with the app by users

  Evaluate the useability and interaction with the app by users ; MAUQ-E

  Day 21

• Evaluate ability to recruit this specific patient and carer population into a research trial

  Evaluate ability to recruit this specific patient and carer population into a research trial ; recruitment rate

  18 months

• Evaluate ability to recruit this specific patient and carer population into a research trial

  Evaluate ability to recruit this specific patient and carer population into a research trial ; numbers approached versus numbers recruited

  18 months

• Evaluate ability to recruit this specific patient and carer population into a research trial

  Evaluate ability to recruit this specific patient and carer population into a research trial ; percentage who complete the study period

  18 months

• Evaluate ability to recruit this specific patient and carer population into a research trial

  Evaluate ability to recruit this specific patient and carer population into a research trial ; questionnaire completion rates

  18 months

Study Arms (1)

PEG tube electively inserted

Adults ≥18 years and/or the carer of a person ≥18 having a PEG tube electively inserted

Other: Albert Health app

Interventions

Albert Health app OTHER

Test an existing digital health app, called Albert Health, designed to support patients with a newly inserted feeding tube to use and manage their tube care, in a feasibility study.

PEG tube electively inserted

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients (adults) seen at New Cross Hospital or City Sandwell Hospital undergoing an elective percutaneous endoscopic gastrostomy will be approached. Participants may be recruited in the following partnerships: i) Primary app user is patient, who will be self-caring, willing to take part and able to consent ii) Co-primary app - patient and carer, both willing to take part and sharing the tube care and able to consent iii) Primary app user is carer providing most or all tube care, willing to take part, carer consent 1. Patient willing to consent - patient consent 2. Patient unable to consent- consultee consent There is no upper age limit for participation.

You may qualify if:

• Person ≥18 and/or the carer of a person ≥18 having a PEG tube electively inserted; the participant or their supporting carer must be literate in English.
• Written informed consent for study participation obtained from the patient or personal consultee (friend/family), with assent as appropriate by the patient, depending on the level of understanding.
• a. Where a personal consultee is the primary participant (ie user of the app) it must be understood that data will be required and collected on the person they are supporting with the app and PEG tube.
• Willingness to comply with all study requirements.
• The participant or carer must have access to a smart phone or mobile device (such as a pad).

You may not qualify if:

• Person being discharged to a nursing home
• Both participant and carer are visually impaired.
• Patient's whose PEG care will be solely provided by district nurses or professional health care workers
• Patient has major surgery scheduled within 7 days of the PEG insertion date

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

Location

Study Officials

• Helen Steed

  Royal Wolverhampton NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen Steed

CONTACT

01902 694009; helen.steed@nhs.net

Lorraine Jacques

CONTACT

01902 695065; lorraine.jacques@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 13, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

GB (1)