Improving Information to Caregivers Via Adaptation and Implementation of the HERMES Intervention

NCT ID: NCT04437563

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-07-15

Brief Summary

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The HERMES intervention was developed in a Danish setting after a comprehensive investigation on caregivers' needs. The intervention consists of: 1) a systematic identification of the caregiver's unmet information needs and 2) a subsequent consultation with a nurse providing the lacking information. The evaluation carried out in a randomized trial at Herlev Hospital showed positive results. It reduced the unmet information needs and improved the caregivers' evaluation of the information from and communication with the health care professionals and the perception of being seen and acknowledged as a caregiver. However, although research projects may show a positive effect, this does not mean that the intervention will be easily implemented in the health care system. Nor does it guarantee that the intervention will show the expected results once implemented in a busy clinical routine.

Therefore, the present project will adapt the HERMES intervention to be implemented in Danish departments of oncology and haematology by (in the first part of the project):

1. Elucidating how the HERMES intervention is best implemented in the clinical setting according to the clinical staff.
2. Elucidating how the HERMES intervention is best implemented in the treatment and follow-up period according to the patients and their caregivers.
3. Developing a technological solution (an app) for the HERMES intervention in which the responses given by the caregivers will form the basis for a subsequent consultation with the health care staff.
4. Revising the HERMES intervention based on the outcomes of a-c.
5. Testing the revised HERMES intervention in a pilot study.

In the second part of the project, the revised HERMES intervention will be tested in a large scale trial with the purpose to:

1. Implement the revised HERMES intervention in the departments of oncology/haematology.
2. Test the effect of the revised HERMES intervention.
3. Evaluate the feasibility of the revised HERMES intervention in a large scale.
4. Elucidate the effectiveness and the feasibility of the intervention and assess possibilities and potential needs for further adaptation in order to secure the future applicability in the Danish Health Care System.

Thus, the overall aim is that by the end of the study, an evidence based and practical implementable method to (continous) use of the HERMES intervention in the Danish health care system is available.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A stepped wedge cluster randomized controlled trial. All clusters (i.e., participating oncological departments) will start as controls and will change to intervention at various times determined by randomization. In this way, all departments will contribute to control and intervention groups, thus accounting for variation between departments.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control

('Standard' care). No intervention offered.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

('Standard' care +) The 'Herlev Hospital Empowerment of Relatives through More and Earlier information Supply' (HERMES) intervention.

Group Type EXPERIMENTAL

HERMES

Intervention Type BEHAVIORAL

Via an app, the caregiver answers 14 questions about his/her need for (more) information. The caregiver presents his/her answers (i.e., need for information) to the health care professionals (HCPs), and the HCPs provide the caregiver with the lacking information.

Interventions

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HERMES

Via an app, the caregiver answers 14 questions about his/her need for (more) information. The caregiver presents his/her answers (i.e., need for information) to the health care professionals (HCPs), and the HCPs provide the caregiver with the lacking information.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adult (18+ years)
* Primary caregiver (defined as the lay person (partner, family member, friend, etc) most involved in the patient's disease course. The primary caregiver is appointed by the patient)
* Caregiver of an adult cancer patient starting up a treatment course in an oncological department
* Written informed consent to participation

Exclusion Criteria

* Caregivers not able to read and understand Danish
* Caregivers with no or minimal contact to the oncological department
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herlev Gentofte University Hospital, Denmark

UNKNOWN

Sponsor Role collaborator

Rigshospitalet, University of Copenhagen, Denmark

UNKNOWN

Sponsor Role collaborator

South Jutland Hospital, Denmark

UNKNOWN

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mogens Groenvold

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mogens Groenvold, PhD DMSc

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg and Frederiksberg Hospital, University of Copenhagen

Locations

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Aalborg Universitetshospital

Aalborg, , Denmark

Site Status RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Herlev Hospital

Herlev, , Denmark

Site Status RECRUITING

Hospitalsenheden Vest

Herning, , Denmark

Site Status RECRUITING

Naestved Sygehus

Næstved, , Denmark

Site Status RECRUITING

Roskilde Universitetshospital

Roskilde, , Denmark

Site Status RECRUITING

Sygehus Soenderjylland

Sønderborg, , Denmark

Site Status RECRUITING

Vejle Sygehus

Vejle, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Mathilde Adsersen, PhD

Role: CONTACT

004538635131

Facility Contacts

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Charlotte B Rotboel, MD

Role: primary

Ulla B Tange, MD

Role: primary

Katrine R Jervad, Nurse

Role: primary

Hanne Linnet, MD

Role: primary

Elizabeth Rosted, PhD, Nurse

Role: primary

Elizabeth Rosted, PhD, Nurse

Role: primary

Joan Lassen, Nurse

Role: primary

Hroenn Thorn, Nurse

Role: primary

Other Identifiers

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R210-A12901

Identifier Type: -

Identifier Source: org_study_id

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