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An Educational tool targeting the symptoms of constipation among people prescribed Clozapine.

Addressing the prevalence and severity of clozapine-induced constipation in adults with schizophrenia or schizoaffective disorder using a nurse-delivered education session: A randomised controlled trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001053617
Acronym
CONSTIP
Enrollment
66
Registered
2023-09-29
Start date
2023-10-23
Completion date
2024-03-04
Last updated
2023-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

consumers prescribed Clozapine suffer from constipation; essentially double that of the general population. Clozapine consumers are 3 times more likely to develop constipation, compared to their contemporaries prescribed other antipsychotics. Ongoing questioning and screening by mental health professionals is strongly recommended, in order to detect and treat constipation in a timely manner. In my experience as a mental health case manager, and more recently as a Clozapine coordinator, the screening, detection, and management of clozapine induced constipation is severely lacking. Non-pharmacological interventions are considered the first and most important step in managing constipation. One hour of exercise, five days a week; increased fibre and fluid intake. These can be achieved with minimal support clinically, and financially. Clozapine clinics have been seen as a place to develop health agency and providing education during clinics, with a view to have the consumers engage in their own treatment interventions for constipation would be the goal. I would aim to incorporate the peer workforce and current consumers prescribed clozapine in the development of the education aspect. This RCT will consist of a control and intervention group. The control group will receive current health practices, which include 3 monthly screening and assessment for constipation by a registered nurse and /or physician. The intervention group will receive an hour of education, targeted at improving their knowledge and understanding of constipation, and given them lifestyle interventions to manage it. All participants will complete a 2 weekly constipation self-report measure called the PAC - SYM to collect data.

Interventions

The intervention will consist of a one hour educational session with a registered nurse, and a brochure to take home. The educational material will incorporate definitions of constipation, risk factors, signs and symptoms, and non-pharmacological interventions. Pharmacological interventions will be noted, with a view to consult with their physician regarding medications. The educational intervention will be conducted via one-to-one sessions, alongside a routine appointment with the clozapine cl

The intervention will consist of a one hour educational session with a registered nurse, and a brochure to take home. The educational material will incorporate definitions of constipation, risk factors, signs and symptoms, and non-pharmacological interventions. Pharmacological interventions will be noted, with a view to consult with their physician regarding medications. The educational intervention will be conducted via one-to-one sessions, alongside a routine appointment with the clozapine clinic. A PowerPoint presentation will be provided, with opportunity following to discuss the subject matter, and answer any questions. The brochure has been specifically been designed for this project. The non-pharmacological interventions consist of commencing or increasing cardiovascular activity via exercise, and increase in fluid intake, and increase in fibre intake, with suggested methods of doing so (foods with known high fibre content) and behavioural modifications - Making a routine to attempt passing stool, making an exercise routine.

Sponsors

Sydney Local Health District
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

A diagnosis of schizophrenia or schizoaffective disorder, prescribed Clozapine.

Exclusion criteria

A formal diagnosis of an intellectual disability, or cognitive disorder, impacting ability to provide informed consent. Similarly, any consumer with an appointed decision maker.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026