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An E-health Letter Intervention for Caregivers

NCT ID: NCT05882461

Last Updated: 2023-05-31

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

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-17

Study Completion Date

2024-03-31

Brief Summary

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The purpose of the present study is to conduct a two-arm Randomized Control Trial (RCT) comparing individuals receiving the 90Second Caregiver health letter, with a usual care (routine care received by caregivers) control group.

The goals of the present study are:

* To evaluate the effectiveness of the 90Second Caregiver health letter in improving caregiver's self-efficacy (primary outcome), savouring, and quality of life (secondary outcomes).
* To evaluate the effectiveness of the 90Second Caregiver health letter in reducing caregiver's psychological strain and caregiver burden (secondary outcomes).
* To examine the impact of levels of engagement with the 90Second Caregiver health letter on primary and secondary outcomes.
* To assess the usability of the 90Second Caregiver health letter, as it relates to the relevance of topic, user friendliness, and appropriateness of the readability levels.
* To evaluate psychometric properties of self-constructed measures in 90Second newsletter.

Detailed Description

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The present study will examine the effectiveness of the 90Second Caregiver health letter in increasing self-efficacy in a sample of informal caregivers of ABI survivors in Nova Scotia. Participants in this study will be recruited from the Caring Forward Trials within Cohort Study (REB#1025253). The study is funded by the Nova Scotia Department of Health and Wellness.

Conditions

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Caregivers Acquired Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The investigators will conduct a two-arm Randomized Control Trial (RCT), comparing a group assigned to receive the 90Second Caregiver Caregiver health letter, with a usual care control group.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
In sequence of eligibility, participants will be randomized to the treatment arm or the control arm, with a 1:1 allocation ratio stratified by gender. The randomization sequence will be generated by a trained person that is not related to the study participants in any way. The investigators and study staff will be blinded to the randomization sequence until the end of the study. Participant randomization will be performed in REDCap. REDCap maintains an automated audit trail which includes the assigned study identification number, treatment allocation, and date and time of the allocation assignment.

Study Groups

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Those receiving the 90Second Caregiver health letter

The 90Second Caregiver health letter is a weekly online publication that addresses topics relevant for caregivers. It combines scientifically-valid, evidence-based information with actionable tips to improve caregiver self efficacy and well-being. Participant in this group will receive a 90Second Caregiver health letter every week, via email.

Group Type EXPERIMENTAL

90Second Caregiver health letter

Intervention Type BEHAVIORAL

Participant receives the weekly health letter via email

The usual care control group

Participants that are randomized to be in the usual care control group will continue on as participants in the Caring Forward Trials within Cohort Study (i.e. filling out questionnaires every 6-months). Participants will continue to participate in the Caring Forward Study until completion in March 2022.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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90Second Caregiver health letter

Participant receives the weekly health letter via email

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Participant is currently enrolled in the Caring Forward Trials within Cohort study (REB#1025253)
* Participant has agreed to be contacted for future studies by Dr. McGrath's staff
* Participant has agreed for their data to be used for future studies
* Participant has mild levels of distress, as indicated by mild scores on the DASS-21 and/or the ZBI-SF

Exclusion Criteria

* Participant is NOT currently enrolled in the Caring Forward Trials within Cohort study (REB#1025253)
* Participant has NOT agreed to be contacted for future studies by Dr. McGrath's staff
* Participant has NOT agreed for their data to be used in future studies
* Participant does NOT report mild levels of distress, as indicated by mild scores on the DASS-21 and/or the ZBI-SF
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IWK Health Centre

OTHER

Sponsor Role lead

Responsible Party

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Patrick J. McGrath

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IWK Health Centre

Halifax, Nova Scotia, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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Andre Lauzon

Role: primary

Other Identifiers

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1025834

Identifier Type: -

Identifier Source: org_study_id