An E-health Letter Intervention for Caregivers

NCT05882461 | Unknown

• 1 other identifier: 1025834
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregivers; Acquired Brain Injury

Outcome Measures

Primary Outcomes (5)

• Caregiving self-efficacy

  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.

  [Time Frame: At baseline.]

• Caregiving self-efficacy

  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.

  [Time Frame: Six months following baseline.]

• Caregiving self-efficacy

  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.

  [Time Frame: Twelve months following baseline.]

• Caregiving self-efficacy

  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.

  [Time Frame: Eighteen months following baseline.]

• Caregiving self-efficacy

  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.

  [Time Frame: Twenty four months following baseline.]

Secondary Outcomes (20)

• Psychological strain

  [Time Frame: At baseline.]

• Psychological strain

  [Time Frame: Six months following baseline.]

• Psychological strain

  [Time Frame: Twelve months following baseline.]

• Psychological strain

  [Time Frame: Eighteen months following baseline.]

• Psychological strain

  [Time Frame: Twenty four months following baseline.]

Other Outcomes (1)

• Usability of the 90Second Caregiver health letter

  through study completion, an average of 1 year

Study Arms (2)

Those receiving the 90Second Caregiver health letter

EXPERIMENTAL

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.

Behavioral: 90Second Caregiver health letter

The usual care control group

NO INTERVENTION

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.

Interventions

90Second Caregiver health letter BEHAVIORAL

Participant receives the weekly health letter via email

Those receiving the 90Second Caregiver health letter

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IWK Health Centre: lead

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, Canada

RECRUITING

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: May 31, 2023
• Study Start: February 17, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CA (1)