Role, NursesROLE-APNCT04726696
Clarification of Nurses' Expected Role in Health Promotion
A study testing ROLE-AP programme in people with Role, Nurses, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
The purpose of this study is to implement and evaluate ROLE-AP, a multi-component program to clarify primary care nurses' expected role in health promotion. It is hypothesized that, in comparison with the control group, participants in the experimental group will increase their degree of agreement on nurses' role in… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Role, Nurses
- What is being tested?
- ROLE-AP programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 21 Feb 2021to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- being a primary care nurse in the Navarre health service.
- have two years of professional experience in primary health care
- be a nurse attending either adult or pediatric population
- have signed the consent form for participation in the study
Who cannot join
- not planning to be in clinical practice for the whole duration of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clarification of Nurses' Expected Role in Health Promotion: Study Protocol of an Exploratory Clustered Randomised Controlled Trial for the ROLE-AP Program
The purpose of this study is to implement and evaluate ROLE-AP, a multi-component program to clarify primary care nurses' expected role in health promotion. It is hypothesized that, in comparison with the control group, participants in the experimental group will increase their degree of agreement on nurses' role in health promotion.
Read the detailed description
Role confusion is hampering the development of primary care nurses' capacity for health promotion. Organizations can implement role clarification programs to develop the description of an expected role in the organization and reduce the negative effects of role confusion. Literature on role clarification interventions reveal that they are complex interventions seeking discussion to reach agreement between professionals about the expected role activities. However, such interventions have shown several methodological shortcomings. This study aims to implement and evaluate a multi-component program to clarify primary care nurses' role in health promotion. An exploratory clinical trial will help evaluate the preliminary efficacy and understand if an intervention of these characteristics is feasible, if its components are appropriate and / or if it is accepted by the participants. This is a pilot cluster randomized exploratory trial, which corresponds to Phase II of the Medical Research Council (MRC) framework for the development and evaluation of clinical trials in complex interventions. The study will be conducted in the province of Navarra (Spain), in the primary health care service. The study will follow a cluster randomised design with primary care teams (PCT) as sampling units. A PCT consists of a group of family physicians who work in close cooperation with nurses and social workers to offer primary care services to registered individuals in the area. Each cluster will be randomly assigned to one of the two groups, control or intervention. The main reason for using a cluster design is to avoid contamination, which could occur among nurses working in the same PCT. The randomisation of the study groups will be stratified according to the scope of work (rural / urban), to guarantee the representativeness of the different segments of the study population. It has been considered that nurses' activities and the perception they may have about their health promoting role may be conditioned by two factors: the organization and structure of the PCT and the characteristics of the populations they attend. These two factors may vary depending on the team attending rural or urban population, so it will be considered as a possible confusing variable. The control group will continue with their routine.
- Conditions
- Role, Nurses
- Being tested
- ROLE-AP programme
- Keywords
- Role clarification, Nurses' role, Health promotion, Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROLE-AP programmeBehavioural
The intervention group will be split in two groups of 7-8 primary care nurses each. These two groups will receive the ROLE-AP program over a three weeks period. Each workshop will be divided into two sessions of 90-120min. The first workshop focuses on the clarification of health promotion concepts and the discussion of the state of nursing practice in health promotion. Participants will discuss the misalignments between this description of nursing practice and the ideal one portrayed by the Ottawa Charter. The second workshop will allow the presentation of the objectives of the health care organization, showing its alignment with the Ottawa Charter areas of action. In addition, it will present a standardized instrument that reflects expectations about nurses' activities in health promotion that will serve for discussing and realigning participants' expectations on nurses' role in health promotion. The third workshop will continue with the discussion of nurses' expected activities.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | None intervention to be administered, they continue their normal routine. |
| Intervention group | Experimental | ROLE-AP is a multifaceted program offered over a month period to participating primary care nurses and includes three interactive workshops. Each workshop will be 4 hours long. Receives: Behavioral: ROLE-AP programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on nurses' agreement on their role using the Spanish version of "Nurses' Role in Health Promotion Questionnaire"
Nurses will complete the questionnaire at 3 time points.
Measured: Baseline (T0), immediately after intervention (T1) and 3 months follow up (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start21 Feb 2021
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Role, NursesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be conducted in the province of Navarra (Spain), in the primary health care service. The study will follow a cluster randomised design with primary care teams (PCT) as sampling units. A PCT consists of a group of family physicians who work in close cooperation with nurses and social workers to offer primary care services to registered individuals in the area. Each cluster will be randomly assigned to one of the two groups, control or intervention. The main reason for using a cluster design is to avoid contamination, which could occur among nurses working in the same PCT. This is more likely given the particular characteristics of this complex intervention in which masking is not possible. The R software (version 3.3.0) will be used to choose an allocation at random. The randomisation of the study groups will be stratified according to the scope of work (rural / urban), to guarantee the representativeness of the different segments of the study population.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Government of Navarra, Universidad Pública de Navarra
- Responsible party
- Sponsor
- Investigators
- Iriarte, Principal investigator, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726696
- Sponsor's protocol ID
- GºNa15/19
- Acronym
- ROLE-AP
- Status last verified
- Jul 2020
- First submitted
- 14 Jan 2021
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Iriarte-Roteta A, Lopez-Dicastillo O, Mujika A, Antonanzas-Baztan E, Hernantes N, Galan Espinilla MJ, Pumar-Mendez MJ. Building capacity for health promotion by addressing nurses' role confusion: Study protocol of a pilot clustered randomised controlled trial. J Adv Nurs. 2021 Nov;77(11):4574-4585. doi: 10.1111/jan.15018. Epub 2021 Aug 21.
PubMed 34418139
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clarification of Nurses' Expected Role in Health Promotion: Study Protocol of an Exploratory Clustered Randomised Controlled Trial for the ROLE-AP Program
- ClinicalTrials.gov ID
- NCT04726696
- Acronym / sponsor ID
- ROLE-AP / GºNa15/19
- Conditions
- Role, Nurses
- Keywords
- Role clarification, Nurses' role, Health promotion, Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- Government of Navarra, Universidad Pública de Navarra
- Study start
- 21 Feb 2021 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 27 Jan 2021 (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 purpose of this study is to implement and evaluate ROLE-AP, a multi-component program to clarify primary care nurses' expected role in health promotion. It is hypothesized that, in comparison with the control group, participants in the experimental group will increase their degree of agreement on nurses' role in health promotion.
Detailed description
Role confusion is hampering the development of primary care nurses' capacity for health promotion. Organizations can implement role clarification programs to develop the description of an expected role in the organization and reduce the negative effects of role confusion. Literature on role clarification interventions reveal that they are complex interventions seeking discussion to reach agreement between professionals about the expected role activities. However, such interventions have shown several methodological shortcomings. This study aims to implement and evaluate a multi-component program to clarify primary care nurses' role in health promotion. An exploratory clinical trial will help evaluate the preliminary efficacy and understand if an intervention of these characteristics is feasible, if its components are appropriate and / or if it is accepted by the participants. This is a pilot cluster randomized exploratory trial, which corresponds to Phase II of the Medical Research Council (MRC) framework for the development and evaluation of clinical trials in complex interventions. The study will be conducted in the province of Navarra (Spain), in the primary health care service. The study will follow a cluster randomised design with primary care teams (PCT) as sampling units. A PCT consists of a group of family physicians who work in close cooperation with nurses and social workers to offer primary care services to registered individuals in the area. Each cluster will be randomly assigned to one of the two groups, control or intervention. The main reason for using a cluster design is to avoid contamination, which could occur among nurses working in the same PCT. The randomisation of the study groups will be stratified according to the scope of work (rural / urban), to guarantee the representativeness of the different segments of the study population. It has been considered that nurses' activities and the perception they may have about their health promoting role may be conditioned by two factors: the organization and structure of the PCT and the characteristics of the populations they attend. These two factors may vary depending on the team attending rural or urban population, so it will be considered as a possible confusing variable. The control group will continue with their routine.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be conducted in the province of Navarra (Spain), in the primary health care service. The study will follow a cluster randomised design with primary care teams (PCT) as sampling units. A PCT consists of a group of family physicians who work in close cooperation with nurses and social workers to offer primary care services to registered individuals in the area. Each cluster will be randomly assigned to one of the two groups, control or intervention. The main reason for using a cluster design is to avoid contamination, which could occur among nurses working in the same PCT. This is more likely given the particular characteristics of this complex intervention in which masking is not possible. The R software (version 3.3.0) will be used to choose an allocation at random. The randomisation of the study groups will be stratified according to the scope of work (rural / urban), to guarantee the representativeness of the different segments of the study population.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –None intervention to be administered, they continue their normal routine. |
| Intervention group | Experimental | Behavioral: ROLE-AP programmeROLE-AP is a multifaceted program offered over a month period to participating primary care nurses and includes three interactive workshops. Each workshop will be 4 hours long. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- being a primary care nurse in the Navarre health service.
- have two years of professional experience in primary health care
- be a nurse attending either adult or pediatric population
- have signed the consent form for participation in the study
Key exclusion criteria (1 listed)
- not planning to be in clinical practice for the whole duration of the study.
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 |
|---|---|---|
| ROLE-AP programmeThe intervention group will be split in two groups of 7-8 primary care nurses each. These two groups will receive the ROLE-AP program over a three weeks period. Each workshop will be divided into two sessions of 90-120min. The first workshop focuses on the clarification of health promotion concepts and the discussion of the state of nursing practice in health promotion. Participants will discuss the misalignments between this description of nursing practice and the ideal one portrayed by the Ottawa Charter. The second workshop will allow the presentation of the objectives of the health care organization, showing its alignment with the Ottawa Charter areas of action. In addition, it will present a standardized instrument that reflects expectations about nurses' activities in health promotion that will serve for discussing and realigning participants' expectations on nurses' role in health promotion. The third workshop will continue with the discussion of nurses' expected activities. | Behavioural | Intervention group |
Primary outcome
Changes on nurses' agreement on their role using the Spanish version of "Nurses' Role in Health Promotion Questionnaire"
Time frame: Baseline (T0), immediately after intervention (T1) and 3 months follow up (T2)
Nurses will complete the questionnaire at 3 time points.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Derived from this study: PubMed 34418139Iriarte-Roteta A, Lopez-Dicastillo O, Mujika A, Antonanzas-Baztan E, Hernantes N, Galan Espinilla MJ, Pumar-Mendez MJ. Building capacity for health promotion by addressing nurses' role confusion: Study protocol of a pilot clustered randomised controlled trial. J Adv Nurs. 2021 Nov;77(11):4574-4585. doi: 10.1111/jan.15018. Epub 2021 Aug 21.
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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.
Iriarte principal investigator
University of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROLE-AP programme in people with Role, Nurses, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
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 4 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: status not confirmed, as of the sponsor's last update on 22 Jun 2021. 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 Spain. 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?
Results are not available in the source record.
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?
Changes on nurses' agreement on their role using the Spanish version of "Nurses' Role in Health Promotion Questionnaire" (time frame: Baseline (T0), immediately after intervention (T1) and 3 months follow up (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04726696, which also lists 1 linked publication.
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 22 Jun 2021.