NCT04726696

Brief 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 health promotion.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

February 21, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

June 22, 2021

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

January 14, 2021

Last Update Submit

June 21, 2021

Conditions

Keywords

Role clarificationNurses' roleHealth promotionPrevention

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (T0), immediately after intervention (T1) and 3 months follow up (T2)

Other Outcomes (5)

  • Barriers to program implementation assessed by the researcher's field diary (Feasibility)

    Baseline (T0)

  • Fidelity of the program assessed by the "ROLE-AP program checklist" (Quality)

    During the intervention

  • Acceptability of the program by nurses, assessed by the "Nurses' satisfaction with the ROLE-AP program questionnaire"

    Immediately after intervention

  • +2 more other outcomes

Study Arms (2)

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.

Behavioral: ROLE-AP programme

Interventions

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.

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- not planning to be in clinical practice for the whole duration of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (1)

  • 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.

Study Officials

  • Iriarte

    University of Navarra

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2021

First Posted

January 27, 2021

Study Start

February 21, 2021

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

June 22, 2021

Record last verified: 2020-07

Locations