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Clinical Trials/NCT04437563
NCT04437563UnknownNot Applicable

Improving Information to Caregivers Via Adaptation and Implementation of the HERMES Intervention the Danish Health Care System

Bispebjerg Hospital8 sites in 1 country1,500 target enrollmentStarted: February 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
1,500
Locations
8
Primary Endpoint
Quality of information from and communication with health care professionals

Study Overview

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. 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Intervention

Experimental

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

Intervention: HERMES (Behavioral)

Control

No Intervention

('Standard' care). No intervention offered.

Outcomes

Primary Outcomes

Quality of information from and communication with health care professionals

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

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.

Secondary Outcomes

  • Quality of information from and communication with health care professionals(Change from baseline (enrollment) to 6 months follow-up)
  • Attention from health care professionals(Change from baseline (enrollment) to 6 months follow-up)
  • Positive emotional functioning(Change from baseline (enrollment) to 6 months follow-up)
  • Amount of information from health care professionals(Change from baseline (enrollment) to 6 months follow-up)
  • Caregiver involvement(Change from baseline (enrollment) to 6 months follow-up)
  • Emotional functioning(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)
  • Attention from health care professionals(Change from baseline (enrollment) to 3 months follow-up)
  • Caregiver involvement(Change from baseline (enrollment) to 3 months follow-up)
  • Emotional functioning(Change from baseline (enrollment) to 3 months follow-up)
  • Positive emotional functioning(Change from baseline (enrollment) to 3 months follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mogens Groenvold

Professor

Bispebjerg Hospital

Study Sites (8)

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