Disabilities, IntellectualNCT06160102
Appropriate Medication Use for Individuals With Intellectual Disabilities - A Matter of Life
A study testing Develop and implement the Framework for safe drug use in people with intellectual and/or developmental disabilities in people with Disabilities, Intellectual and Disability, Developmental, run by Vestvagoy Municipality at 1 site in Norway.
Trial summary
The innovation idea is to develop valuable new knowledge about safe drug use in people with intellectual and/or developmental disabilities (IDDs). The main goal is to design a framework (routines and processes) that ensures safe drug use and provides qualitatively better services for people with IDDs. Read more about this study
- Who is it for?
- Ages 1 year to 99 years
- Conditions the study is for
- Disabilities, Intellectual, Disability, Developmental
- What is being tested?
- Develop and implement the Framework for safe drug use in people with intellectual and/or developmental disabilities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteNorway
- Study dates
- 15 Aug 2023to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Users of the municipality's Service for people with disabilities
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The innovation idea is to develop valuable new knowledge about safe drug use in people with intellectual and/or developmental disabilities (IDDs). The main goal is to design a framework (routines and processes) that ensures safe drug use and provides qualitatively better services for people with IDDs. Secondary goals are that employees will experience better security when working with medicines, and interact better with people with IDD and relatives by implementing digital support functions. The innovation idea is specifically to develop/improve the following: 1) Medication management: Coordinating routines, procedures and work processes regarding all aspects of drug use, medication handling, and communication between care units for people with IDDs. 2) Medication therapy: Chart review of prescribed medication and gather knowledge about challenges related to drug use in this group. Based on this, we will develop new methods for drug reconciliation and medication reviews to optimize drug use. 3) New framework for safe drug use in the community-based services for people with IDDs.
Read the detailed description
Changing, developing, and testing new routines, procedures, and communication methods for safe drug use is challenging. The complexity of systems that are involved in medication management makes it particularly challenging to create well-designed digital solutions that ensure good working procedures. The complex issues faced by people with IDDs, as well as developments within personalized medicine, means that it is crucial to build new knowledge, work in teams, and arrange for medication reconciliation and medication reviews to be carried out regularly. Furthermore, drug information must be provided, and adapted to the specific individual with an intellectual disability. In addition, the focus on personalized medicine means that the municipality must develop new guidelines for the use of pharmacogenetic tests so that the doctor can tailor drug selection and dosage to the individual patient.
- Being tested
- Develop and implement the Framework for safe drug use in people with intellectual and/or developmental disabilities
- Keywords
- Intellectual Disabilities, Developmental Disabilities, Intersectoral Collaboration, Medication Therapy Management, Medication Reconciliation, Medication Review
- Medical subject headings
- Intellectual Disability, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Develop and implement the Framework for safe drug use in people with intellectual and/or developmental disabilitiesOther
Collection and analysis of drug lists and information about the users. Open / participatory observations of staff and residents during drug handling. Interviews/focus groups with residents, family, staff in the service, GPs and pharmacy staff. Interdisciplinary drug reviews based on the IMM method drug reviews, further developed by the researchers in the project.
Design thinking. We use a design process with five stages: empathy, define, generate ideas, prototype and test. This involves user participation and experience to design the most optimal solution for the framework.
Evaluate the framework, observations, interviews, questionnaires. Health economic evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Framework for safe drug use in people with intellectual and/or developmental disabilities | Other | Optimizing medication management and medication therapy poses complex challenges related to the different groups, actors, and not least the data systems. To meet these challenges, we have chosen a method where the participants contribute actively in the research: participatory action research (PAR). This method involves both the action and the knowledge production being done in collaboration between all the participants, since neither the researcher nor others have exclusive right to the understanding of reality.
Normalization process theory offers an analytical tool that helps to understand and explain the dynamic processes that occur during the implementation of complex interventions and technological and organizational innovations in health care, which includes institutional and organizational contexts and focuses on what social processes can promote and inhibit it through the integration of new routines and work forms in established social structures. Receives: Other: Develop and implement the Framework for safe drug use in people with intellectual and/or developmental disabilities |
What is being measured
The primary outcome is the main question the study is designed to answer.
To understand what is safe drug therapy and drug handling in people with intellectual and/or developmental disabilities
Map which drugs each patient uses and carry out medication reconciliation (nurse and pharmacist) and medication review (nurse, pharmacist and general general practitioner).
Interviews of employees, GPs and pharmacy staff.
Measured: 12 months
Formulation of multidisciplinary frameworks for optimizing drug handling and drug therapy.
Design thinking and co-creation of multidisciplinary frameworks
Measured: 18 months
Explore usefulness of multidisciplinary frameworks
Transcripts of qualitative feedback. Follow-up survey of employees, GPs, pharmacy staff, and people with intellectual and/or developmental disabilities. Health economic evaluation.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start15 Aug 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disabilities, IntellectualStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participatory action research
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vestvagoy Municipality
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, University of Tromso
- Responsible party
- Principal investigator, Solrun Gjertine Holm, Vestvagoy Municipality
- Investigators
- Heidi Wiik, MBA, Study director, Vestvågøy Municipality
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160102
- Sponsor's protocol ID
- 22/658-6
- Other IDs
- Project number: 341297
- Status last verified
- Nov 2025
- First submitted
- 18 Oct 2023
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriate Medication Use for Individuals With Intellectual Disabilities - A Matter of Life
- ClinicalTrials.gov ID
- NCT06160102
- Acronym / sponsor ID
- 22/658-6
- Keywords
- Intellectual Disabilities, Developmental Disabilities, Intersectoral Collaboration, Medication Therapy Management, Medication Reconciliation, Medication Review
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Vestvagoy MunicipalityUniversity, hospital or other
- Collaborators
- University of Oslo, University of Tromso
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The innovation idea is to develop valuable new knowledge about safe drug use in people with intellectual and/or developmental disabilities (IDDs). The main goal is to design a framework (routines and processes) that ensures safe drug use and provides qualitatively better services for people with IDDs. Secondary goals are that employees will experience better security when working with medicines, and interact better with people with IDD and relatives by implementing digital support functions. The innovation idea is specifically to develop/improve the following: 1) Medication management: Coordinating routines, procedures and work processes regarding all aspects of drug use, medication handling, and communication between care units for people with IDDs. 2) Medication therapy: Chart review of prescribed medication and gather knowledge about challenges related to drug use in this group. Based on this, we will develop new methods for drug reconciliation and medication reviews to optimize drug use. 3) New framework for safe drug use in the community-based services for people with IDDs.
Detailed description
Changing, developing, and testing new routines, procedures, and communication methods for safe drug use is challenging. The complexity of systems that are involved in medication management makes it particularly challenging to create well-designed digital solutions that ensure good working procedures. The complex issues faced by people with IDDs, as well as developments within personalized medicine, means that it is crucial to build new knowledge, work in teams, and arrange for medication reconciliation and medication reviews to be carried out regularly. Furthermore, drug information must be provided, and adapted to the specific individual with an intellectual disability. In addition, the focus on personalized medicine means that the municipality must develop new guidelines for the use of pharmacogenetic tests so that the doctor can tailor drug selection and dosage to the individual patient.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participatory action research
| Arm | Type | Receives |
|---|---|---|
| Framework for safe drug use in people with intellectual and/or developmental disabilities | Other | Other: Develop and implement the Framework for safe drug use in people with intellectual and/or developmental disabilitiesOptimizing medication management and medication therapy poses complex challenges related to the different groups, actors, and not least the data systems. To meet these challenges, we have chosen a method where the participants contribute actively in the research: participatory action research (PAR). This method involves both the action and the knowledge production being done in collaboration between all the participants, since neither the researcher nor others have exclusive right to the understanding of reality. Normalization process theory offers an analytical tool that helps to understand and explain the dynamic processes that occur during the implementation of complex interventions and technological and organizational innovations in health care, which includes institutional and organizational contexts and focuses on what social processes can promote and inhibit it through the integration of new routines and work forms in established social structures. |
Who may qualify
- Ages
- 1 year to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Users of the municipality's Service for people with disabilities
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Develop and implement the Framework for safe drug use in people with intellectual and/or developmental disabilitiesCollection and analysis of drug lists and information about the users. Open / participatory observations of staff and residents during drug handling. Interviews/focus groups with residents, family, staff in the service, GPs and pharmacy staff. Interdisciplinary drug reviews based on the IMM method drug reviews, further developed by the researchers in the project. Design thinking. We use a design process with five stages: empathy, define, generate ideas, prototype and test. This involves user participation and experience to design the most optimal solution for the framework. Evaluate the framework, observations, interviews, questionnaires. Health economic evaluation. | Other | Framework for safe drug use in people with intellectual and/or developmental disabilities |
Primary outcome
To understand what is safe drug therapy and drug handling in people with intellectual and/or developmental disabilities
Time frame: 12 months
Map which drugs each patient uses and carry out medication reconciliation (nurse and pharmacist) and medication review (nurse, pharmacist and general general practitioner). Interviews of employees, GPs and pharmacy staff.
Formulation of multidisciplinary frameworks for optimizing drug handling and drug therapy.
Time frame: 18 months
Design thinking and co-creation of multidisciplinary frameworks
Explore usefulness of multidisciplinary frameworks
Time frame: 18 months
Transcripts of qualitative feedback. Follow-up survey of employees, GPs, pharmacy staff, and people with intellectual and/or developmental disabilities. Health economic evaluation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Wiik, MBA study director
Vestvågøy Municipality
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Develop and implement the Framework for safe drug use in people with intellectual and/or developmental disabilities in people with Disabilities, Intellectual and Disability, Developmental, run by Vestvagoy Municipality at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To understand what is safe drug therapy and drug handling in people with intellectual and/or developmental disabilities (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.