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

NCT04437563 | Unknown

• 1 other identifier: R210-A12901
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 8

Brief Summary

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. 1.Elucidating how the HERMES intervention is best implemented in the clinical setting according to the clinical staff.
2. 2.Elucidating how the HERMES intervention is best implemented in the treatment and follow-up period according to the patients and their caregivers.
3. 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. 4.Revising the HERMES intervention based on the outcomes of a-c.
5. 5.Testing the revised HERMES intervention in a pilot study.
6. 6.Implement the revised HERMES intervention in the departments of oncology/haematology.
7. 7.Test the effect of the revised HERMES intervention.
8. 8.Evaluate the feasibility of the revised HERMES intervention in a large scale.
9. 9.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.

Conditions

Cancer

Keywords

Cancer; Informal caregivers; Information; Intervention; Stepped wedge cluster randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Quality of information from and communication with health care professionals

  Measured by the subscale 'Problems with the quality of information from and communication with health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more problems with the quality of information from and communication with health care professionals.

  Change from baseline (enrollment) to 3 months follow-up

Secondary Outcomes (11)

• Quality of information from and communication with health care professionals

  Change from baseline (enrollment) to 6 months follow-up

• Amount of information from health care professionals

  Change from baseline (enrollment) to 3 months follow-up

• Amount of information from health care professionals

  Change from baseline (enrollment) to 6 months follow-up

• Attention from health care professionals

  Change from baseline (enrollment) to 3 months follow-up

• Attention from health care professionals

  Change from baseline (enrollment) to 6 months follow-up

Study Arms (2)

Control

NO INTERVENTION

('Standard' care). No intervention offered.

Intervention

EXPERIMENTAL

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

Behavioral: HERMES

Interventions

HERMES 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Caregivers not able to read and understand Danish
• Caregivers with no or minimal contact to the oncological department

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Herlev Gentofte University Hospital, Denmark: collaborator
• Rigshospitalet, Denmark: collaborator
• South Jutland Hospital, Denmark: collaborator

Study Sites (8)

Aalborg Universitetshospital

Aalborg, Denmark

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Herlev Hospital

Herlev, Denmark

RECRUITING

Hospitalsenheden Vest

Herning, Denmark

RECRUITING

Naestved Sygehus

Næstved, Denmark

RECRUITING

Roskilde Universitetshospital

Roskilde, Denmark

RECRUITING

Sygehus Soenderjylland

Sønderborg, Denmark

RECRUITING

Vejle Sygehus

Vejle, Denmark

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

RBPMS protein, human

Study Officials

• Mogens Groenvold, PhD DMSc

  Bispebjerg and Frederiksberg Hospital, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathilde Adsersen, PhD

CONTACT

004538635131; mathilde.adsersen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: February 1, 2021
• Primary Completion: April 15, 2022
• Study Completion: July 15, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-03

Locations

DK (8)