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An E-health Letter Intervention for Caregivers

90Second Caregiver: A Randomized Control Trial of an E-health Letter for Caregivers

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05882461
Acronym
90Second
Enrollment
330
Registered
2023-05-31
Start date
2021-02-17
Completion date
2024-03-31
Last updated
2023-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Brain Injury, Caregivers

Brief summary

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

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.

Interventions

BEHAVIORAL90Second Caregiver health letter

Participant receives the weekly health letter via email

Sponsors

IWK Health Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Caregiving self-efficacy[Time Frame: At baseline.]The Controlling Upsetting Thoughts about Caregiving subscale from the 15-item Revised Scale for Caregiving Self-Efficacy (RSCSE; Steffen et al. 2002), that measure caregivers level of confidence with higher scores indicating higher levels of self-efficacy.

Secondary

MeasureTime frameDescription
Psychological strain[Time Frame: At baseline.]The Depression, Anxiety, and Stress Scale (DASS-21; Lovibond & Lovibond, 1995), a 21-item self-report measure that will assess caregiver's levels of psychological strain over the last week in three distinct categories; depression (e.g. hopelessness, depressed mood), anxiety (e.g. fear, anticipation of negative events), and stress (e.g. prolonged state of arousal, difficulty relaxing).
Caregiver burden[Time Frame: At baseline.]The Zarit Burden Interview-Short Form (ZBI-SF; Bedard et al., 2001), a 12-item measure that assesses individuals' perceived burden of providing care to their loved one.
Savouring[Time Frame: At baseline.]The Savouring Configuration Inventory (SCI; Lauzon & Green-Demers, 2020), which measures hedonic savouring, and eudaimonic savouring of meaning of life, spirituality, self-reflection, inspiration, appreciation, and gratitude. It comprises 28 scenarios (4 subscales), paired with a single item.
Overall quality of life and general health[Time Frame: At baseline.]The World Health Organization Quality of Life Assessment -BREF (WHOQOL-BREF; Whoqol Group, 1998), a 26-item measure that assesses quality of life in four distinct domains: physical health, psychological health, social relationships and the environment. A weighted summary score from 0-100 is calculated for each domain, with higher scores indicating higher quality of life.

Other

MeasureTime frameDescription
Usability of the 90Second Caregiver health letterthrough study completion, an average of 1 yearThe current study will also assess the usability of the 90Second Caregiver health letter by evaluating the relevance of topic, learnability, and acceptability of the program. The usability questionnaire was developed for the current study.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026