Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05671354 |
| Other study ID # |
HKU_commode_protocol_v1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 5, 2023 |
| Est. completion date |
May 3, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
The University of Hong Kong |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study has 4 research questions regarding the use of auto-wrapping commode chairs in
elderly residential setting:
Primary study questions:
1. Can the frequency of the spills of excretions during disposing of excretions be reduced
when auto-wrapping commode chairs are used as compared to conventional commode chairs?
Auxiliary study questions:
2. Can the staff time spent on disposing of excretions from commode chairs be reduced when
auto-wrapping commode chairs are used as compared to conventional commode chairs?
3. What is the satisfaction of the residents and staff on using the auto-wrapping commode
chairs?
4. What are the perceived benefits and feasibility in allowing the residents to use the
auto-wrapping commode chairs?
Description:
Study design
The trial is a single group pre-post study at Haven of Hope Woo Ping Care & Attention Home.
Ten residents, who use conventional commode chair for at least 7 days before the trial, will
use the auto-wrapping commode chair for 7 days. Qualitative interviews will be conducted with
the participants and related staff after the participants finish using the auto-wrapping
commode chair.
This protocol complies with the International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use - Guideline for Good Clinical Practice
(ICH-GCP) and Declaration of Helsinki.
Subjects
Residents of 3 different floors in Haven of Hope Woo Ping Care & Attention Home and their
related care staff will be recruited.
Inclusion criteria of the residents:
- Use conventional commode chair at the bedside for at least 7 days before the trial, or
- Use diapers and is suitable to use auto-wrapping commode chairs, as assessed by a nurse
Inclusion criteria of the staff:
• Are responsible for assisting toileting of the participants, including disposing of
excretions
Exclusion criteria of the residents and staff:
• None
Procedures
1. Training of care staff Care staff will be trained on how to dispose of the excretions
from the auto-wrapping commode chairs and facilitate the participants to use the
auto-wrapping commode chairs. The training will last for around half an hour. A protocol
including related operation will be provided for care staff.
2. Participants' recruitment and consent The care staff and nurses will check the
eligibility of the residents and invite eligible residents to join the trial. Residents
scoring above the cutoff for dementia in Montreal Cognitive Assessment (MoCA) (see
Appendix 1) and not receiving a medical diagnosis of dementia or other mentally
incapacitating disease will be classified as competent in giving consent and will be
invited to give consent. For residents scoring below the cutoff in MoCA or receiving a
diagnosis of mentally incapacitating disease, the criteria stated in the Alzheimer
Europe Report (2011) will be followed to ensure that they are provided chances to give
consent. In particular, four criteria will be evaluated, including 1) the person must
have sufficient capacity to understand the information, 2) the person is able to retain,
use and weight up such information for making a decision, 3) the person will understand
the benefit, risk, and convenience, 4) the person must have the ability to communicate
the decision. The University of Hong Kong (HKU) research staff and the care staff will
first commit them in a causal chat to assess their ability to communicate and understand
the dialogues.
If residents are competent in giving consent, both residents and their family members
will be approached for consent. In cases residents are not competent in giving consents,
only their family members will be approached for consent. They will then be referred to
join a 1-to-1 study introduction session. In this session, HKU research staff and
service unit staff will introduce the study to the participant, and invite them to sign
a consent form. As a voluntary participation, the participants have the right to
withdraw from the study and intervention any time without consequences.
Staff's consent will be sought when they are interviewed about the perceived benefits
and feasibility in allowing the residents to use the auto-wrapping commode chairs.
3. Pre-test Before the use of the auto-wrapping commode chairs, there will be a 7-day
pre-test. During pre-test, at regular times of the day, the standard procedure of
disposing of the excretions from conventional commode chairs will be followed. This
procedure includes transporting the bedpans of the commode chairs to the toilets,
disposing of the excretions into the toilets, and finally transporting these bedpans to
cleaning machines.
In this period, the care staff will record daily the frequency of the spills of
excretions during disposing of excretions from participants' conventional commode chairs
(including transporting and disposing of the excretions to the toilets). The time spent
on disposing of excretions from the conventional commode chairs will be calculated by
multiplying daily frequency of disposing of excretions and average duration of disposing
of excretions. Daily frequency of disposing of excretions will be retrieved from care
routine schedule. Average duration of disposing of excretions will be estimated by three
observations of the process by a HKU research assistant.
In the same pre-test period, the staff will rate daily two items on the satisfaction of
the participants in using, and the staff in allowing the participants to use
conventional commode chairs on a 5- point Likert scale (1 = very unsatisfied; 5 = very
satisfied).
4. Trial period The participants will be trained by the care staff to use the auto-wrapping
commode chair. They will use the auto-wrapping commode chair for 7 days. The
auto-wrapping commode chairs will seal off the excretions in a plastic bag when a button
is pressed, and then prepare a new bag for next excretions. The sealed excretions will
then be disposed of as usual garbage. The same staff, who are responsible for disposing
of the excretions from the commodes in the previous 7 days before the trial, will
dispose of the excretions from the auto-wrapping commode chairs during the trial.
During the trial, the staff will record daily the frequencies of spills of excretions during
disposing of excretions as well as the satisfaction of the participants and the staff to use
auto-wrapping commode chairs. The time spent on disposing of excretions from the
auto-wrapping commode chairs will be calculating by multiplying daily frequency of disposing
of excretions and average duration of disposing of excretions. Daily frequency of disposing
of excretions will be retrieved from care routine schedule. Average duration of disposing of
excretions will be estimated by three observations of the process by a HKU research
assistant.
Qualitative interviews will be conducted with all participants when they finish using the
auto-wrapping commode chairs. 2-3 related staff of each site will be interviewed after all
participants complete or terminate the trial. Interview contents include the perceived
benefits and feasibility in allowing the residents to use the auto-wrapping commode chairs as
compared to conventional commode chairs.
Blinding
No blinding will be done for this single group study.
Sample size determination
The sample size is estimated by the expected number of eligible residents of the sites. A
maximum of 10 participants will be recruited from each site.
Data analysis
1. Main analysis Wilcoxon signed-rank test will be used to examine the difference in the
frequency of the spills of excretions during disposing of excretions between using
auto-wrapping commode chairs and conventional commode chairs, and the difference in the
staff time spent on disposing of excretions from auto-wrapping commode chairs and
conventional commode chairs.
Descriptive statistics will be used to explore the satisfaction on the auto-wrapping
commode chairs.
2. Qualitative interview The qualitative interview content will be transcribed verbatim in
Chinese for further analysis. The qualitative interview transcripts will then be
analyzed using framework analysis to construct a coherent and logical structure from the
classification of many opinions and perceptions of the new health monitoring device. The
results will then be discussed and consolidated in the panel meetings with the
co-authors.
