Enteral Feeding
Conditions
Keywords
Enteral Feeding, Mobility, Quality of Life, Elastomeric
Brief summary
The goal of this interventional study is to obtain information on the safety and effectiveness of a novel enteral feeding system in adult users requiring at least a portion of their nutritional intake via enteral feeding. The main questions it aims to answer are: * Can the device be used safely and effectively? * Does use of the device impact on patient's quality of life? Participants will use Mobility+ enteral feeding system as their enteral feeding method for the duration of the study and will record their experiences.
Detailed description
The study will allow 25 participants to use the Mobility+ system for their feeding sessions over the course of 14 consecutive days, following an initial 7-day period where participants have time to trial and get used to the new system. Participants' homes are the setting for the 21-day study duration.
Interventions
DEVICEMobility+ Enteral Feeding System
Enteral feeding using a continuous feeding, self-powered, discreet, silent enteral feeding system.
Sponsors
Horizon 2020 - European Commission
Rockfield Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
25 adult subjects from a screening population of 200
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with Gastrostomy (G) tube or Jejunostomy (J) tubes * Participant must require enteral tube feeding every day, as determined at the time of study enrolment * Participant must use commercially available enteral formula with standard enteral feeding system(s) (gravity bag, bolus, pump or combination(s)), for some or all of their tube feeds, for daytime or day and night-time feeding * Participant must be EN dependent i.e., 500 ml minimum daily feed intake from EN * Participants must be able to swap from current system to Mobility+ for a minimum of two daily feeds per day for duration of study (Study days 1 -14) * Participant must be \>= 18 to reflect the subset of the intended use population being evaluated * Participant must be willing to participate in the study and provide consent). * Participants must have been on an enteral feeding regime for a minimum of 10 weeks * Participants clinical functional capacity is adequate as determined by operator clinical judgement, to enable them to participate fully in the study * Participants are suitable candidates for using Mobility+ as determined by operator clinical judgement on participant enteral feeding needs (as per prescription) and alignment with Mobility+ Flow Rate Guide
Exclusion criteria
* Participants who do not use commercially available enteral formula for some or all their formula needs * Participants unable/unwilling to provide consent * Participants whose enteral feeding needs do not match the offering of the Mobility+, as determined by operator clinical judgement * Participants who have inadequate clinical functional capacity, as determined by operator clinical judgement to participate fully in the study e.g. neuromuscular or neurodegenerative disorders, or developmental delay * Participants with very limited mobility, as determined by operator clinical opinion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of Enteral Feed Consumed Per Day | 14 days | Volume in mls of enteral feed consumed in total, and with Mobility+ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+ | 14 days | Subjective scale (Likert) - Ease of use of current enteral feeding systems and Mobility+ were rated as: Strongly agree (5), Somewhat agree (4), Neutral (3), Somewhat disagree (2), Strongly disagree (1). |
| Patient Perspective on Feeding Intolerance Symptoms Experienced Using Current Enteral Feeding System and Mobility+ | 14 days | — |
| Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+ | 14 days | Subjective scale (Likert) - Ease of performing activities during feeding rated as: Very easy (5), Easy (4), Neutral (3), Difficult (2), Very difficult (1). |
| Usability of Mobility+ (Volume) | 14 days | Estimate if participants consume similar average volume of feed/day during the study, compared to baseline |
| Usability of Mobility+ (kcal) | 14 days | Estimate if participants consume similar average kcals of feed/day during the study, compared to baseline |
| Participant Perspective on Quality of Life | 14 days | Subjective scale (Likert) - Perspective on Quality of Life rated as: Excellent (5), Good (4), Neutral (3), Bad (2), Very bad (1) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patient Cohort This was a prospective, single arm, single-center, non-randomized, first in human, post-market clinical study. | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Patient Cohort | — |
|---|---|---|
| Age, Continuous | 63.8 Year STANDARD_DEVIATION 12 | — |
| Body Mass Index (BMI) | 23.3 Kilogram per square metre STANDARD_DEVIATION 3.4 | — |
| Daily EN feeding sessions | 2.9 Feeding sessions per day STANDARD_DEVIATION 1.1 | — |
| EN daily calories | 1907 kcal per day STANDARD_DEVIATION 553 | — |
| EN formula consumed | 1174 milliliters per day STANDARD_DEVIATION 353 | — |
| Height | 171.5 Centimetres STANDARD_DEVIATION 9.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
| Total infusion time | 3.0 hours per day STANDARD_DEVIATION 3.5 | — |
| Weight | 69.0 Kilogram STANDARD_DEVIATION 15 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
Volume of Enteral Feed Consumed Per Day
Volume in mls of enteral feed consumed in total, and with Mobility+
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Cohort | Volume of Enteral Feed Consumed Per Day | Volume in milliliters of enteral feed consumed (Mobility+) | 1050 milliliters per day | Standard Deviation 363 |
| Patient Cohort | Volume of Enteral Feed Consumed Per Day | Volume in milliliters of enteral feed consumed (other EN systems) | 256 milliliters per day | Standard Deviation 294 |
Secondary
Participant Perspective on Quality of Life
Subjective scale (Likert) - Perspective on Quality of Life rated as: Excellent (5), Good (4), Neutral (3), Bad (2), Very bad (1)
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Cohort | Participant Perspective on Quality of Life | Quality of life (participant perspective) at baseline | 3.6 Scores on a scale | Standard Deviation 0.9 |
| Patient Cohort | Participant Perspective on Quality of Life | Quality of life (participant perspective) at end of Study, post 14 d feeding w/ Mobility+ (Day 21) | 3.7 Scores on a scale | Standard Deviation 0.8 |
Secondary
Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+
Subjective scale (Likert) - Ease of use of current enteral feeding systems and Mobility+ were rated as: Strongly agree (5), Somewhat agree (4), Neutral (3), Somewhat disagree (2), Strongly disagree (1).
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Cohort | Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+ | System is easy to use (Baseline) | 3.8 Scores on a scale | Standard Deviation 0.8 |
| Patient Cohort | Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+ | System is easy to use (End of Study post 14 d feeding w/ Mobility+ (Day 21)) | 3.5 Scores on a scale | Standard Deviation 1.5 |
| Patient Cohort | Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+ | System is easy to carry (Baseline) | 2.8 Scores on a scale | Standard Deviation 1.4 |
| Patient Cohort | Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+ | System is easy to carry (End of Study post 14 d feeding w/ Mobility+ (Day 21)) | 4.2 Scores on a scale | Standard Deviation 1 |
| Patient Cohort | Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+ | The noise level of system is acceptable (Baseline) | 4.2 Scores on a scale | Standard Deviation 1.2 |
| Patient Cohort | Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+ | The noise level of system is acceptable (End of Study post 14 d feeding w/ Mobility+ (Day 21)) | 4.8 Scores on a scale | Standard Deviation 0.5 |
| Patient Cohort | Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+ | System allows me to feed discreetly (Baseline) | 1.9 Scores on a scale | Standard Deviation 1.2 |
| Patient Cohort | Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+ | System allows me to feed discreetly (End of Study post 14 d feeding w/ Mobility+ (Day 21)) | 3.6 Scores on a scale | Standard Deviation 1.3 |
| Patient Cohort | Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+ | I am satisfied with the overall performance of the system (Baseline) | 3.5 Scores on a scale | Standard Deviation 1.2 |
| Patient Cohort | Patient Perspective on Ease of Use Using Current Enteral Feeding System and Mobility+ | I'm satisfied with overall system performance (End of Study post 14 d feeding w/ Mobility+ (Day 21)) | 3.6 Scores on a scale | Standard Deviation 1.5 |
Secondary
Patient Perspective on Feeding Intolerance Symptoms Experienced Using Current Enteral Feeding System and Mobility+
Time frame: 14 days
Population: This data was not collected for operational reasons as it was considered over burdensome to ask participants these questions due to time pressures during study execution and the extent of questions already posed.
Secondary
Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+
Subjective scale (Likert) - Ease of performing activities during feeding rated as: Very easy (5), Easy (4), Neutral (3), Difficult (2), Very difficult (1).
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Cohort | Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+ | Moving from one room to another (Baseline) | 2.6 Scores on a scale | Standard Deviation 1.2 |
| Patient Cohort | Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+ | Moving from one room to another (End of Study post 14 d feeding w/ Mobility+ (Day 21)) | 4.6 Scores on a scale | Standard Deviation 0.5 |
| Patient Cohort | Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+ | Going up and down stairs (Baseline) | 2.1 Scores on a scale | Standard Deviation 1.3 |
| Patient Cohort | Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+ | Going up and down stairs (End of Study post 14 d feeding w/ Mobility+ (Day 21)) | 4.6 Scores on a scale | Standard Deviation 0.5 |
| Patient Cohort | Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+ | Short walk (e.g 1 block) (Baseline) | 2.3 Scores on a scale | Standard Deviation 1.2 |
| Patient Cohort | Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+ | Short walk (e.g. 1 block) (End of Study post 14 d feeding w/ Mobility+ (Day 21)) | 4.5 Scores on a scale | Standard Deviation 0.6 |
| Patient Cohort | Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+ | Long walk (e.g. several blocks) (Baseline) | 1.9 Scores on a scale | Standard Deviation 1.1 |
| Patient Cohort | Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+ | Long walk (e.g. several blocks) (End of Study post 14 d feeding w/ Mobility+ (Day 21)) | 4.4 Scores on a scale | Standard Deviation 0.7 |
| Patient Cohort | Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+ | Travelling in car/public transport (Baseline) | 2.4 Scores on a scale | Standard Deviation 1.2 |
| Patient Cohort | Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+ | Travelling in car/public transport (End of Study post 14 d feeding w/ Mobility+ (Day 21) | 3.8 Scores on a scale | Standard Deviation 1.1 |
| Patient Cohort | Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+ | Moderate intensity physical activities (Baseline) | 1.8 Scores on a scale | Standard Deviation 1.1 |
| Patient Cohort | Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+ | Moderate intensity physical activities (End of Study post 14 d feeding w/ Mobility+ (Day 21)) | 3.8 Scores on a scale | Standard Deviation 1 |
| Patient Cohort | Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+ | Other daily activities (high intensity physical activities) (Baseline) | 1.8 Scores on a scale | Standard Deviation 1.1 |
| Patient Cohort | Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+ | Other daily high intensity physical activities(End of Study post 14 d feeding w/ Mobility+ (Day 21)) | 3.7 Scores on a scale | Standard Deviation 0.9 |
| Patient Cohort | Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+ | Ability to sleep (Baseline) | 2.9 Scores on a scale | Standard Deviation 1.5 |
| Patient Cohort | Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+ | Ability to sleep (End of Study End of Study post 14 d feeding w/ Mobility+ (Day 21)) | 3.8 Scores on a scale | Standard Deviation 1.1 |
| Patient Cohort | Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+ | Socializing with friends/family (Baseline) | 3.2 Scores on a scale | Standard Deviation 1.1 |
| Patient Cohort | Patient Perspective on Mobility Using Current Enteral Feeding System vs Mobility+ | Socializing with friends/family (End of Study End of Study post 14 d feeding w/ Mobility+ (Day 21)) | 4.3 Scores on a scale | Standard Deviation 0.8 |
Secondary
Usability of Mobility+ (kcal)
Estimate if participants consume similar average kcals of feed/day during the study, compared to baseline
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Cohort | Usability of Mobility+ (kcal) | Total enteral feed kcal consumed per day, at study end, post 14 d feeding w/ Mobility+ (Day 21)) | 2034 kcal per day | Standard Deviation 527 |
| Patient Cohort | Usability of Mobility+ (kcal) | Total enteral feed kcal consumed per day, at baseline | 1848 kcal per day | Standard Deviation 604 |
Secondary
Usability of Mobility+ (Volume)
Estimate if participants consume similar average volume of feed/day during the study, compared to baseline
Time frame: 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Cohort | Usability of Mobility+ (Volume) | Total enteral feed volume consumed per day at baseline | 1174 milliliters per day | Standard Deviation 353 |
| Patient Cohort | Usability of Mobility+ (Volume) | Total enteral feed volume consumed per day at end of Study, post 14 d feeding w/ Mobility+ (Day 21)) | 1306 milliliters per day | Standard Deviation 318 |
| Patient Cohort | Usability of Mobility+ (Volume) | Total enteral feed kcal consumed per day, at baseline | 1848 milliliters per day | Standard Deviation 604 |
| Patient Cohort | Usability of Mobility+ (Volume) | Total enteral feed kcal consumed per day, at study end, post 14 d feeding w/ Mobility+ (Day 21)) | 2034 milliliters per day | Standard Deviation 527 |