A Trial of a Multi-component Individualized Telephone-based Support Intervention for Adult-child Caregivers Caring for Parents With Dementia

NCT03378050 | Withdrawn

• 1 other identifier: Yu12.17
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is the first randomized controlled trial exploring the implementation of a multi-component individualized telephone-based support intervention for adult-child caregivers caring for parents with dementia in China. Results hold the potential to inform the further development of family caregiver supportive services.

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

• Caregiver Burden

  Caregiver burden will be assessed using the 12-item version of Zarit Burden Interview (12-item ZBI) to measure caregiver burden (Bédard, 2001; Zarit, 1980). Each item is rated on a 5-point Likert scale from 0 (never) though 4 (nearly always), yielding a possible range of 0 to 48. Higher scores indicate greater levels of caregiver burden. This short version and The Chinese version of 12-item ZBI has excellent internal consistency (Cronbachα= 0.87); and is highly correlated with the full measure (r = 0.952) (Lin, 2017; Wang, Yand, \& Hou, 2006).

  12 weeks

Secondary Outcomes (5)

• Caregiver Burden

  Baseline, 6 weeks and 24 weeks

• Health Related Quality of Life

  Baseline, 6 weeks, 12 weeks and 24 weeks

• Reciprocal Filial Piety

  Baseline, 6 weeks, 12 weeks and 24 weeks

• BPSD

  Baseline, 6 weeks, 12 weeks and 24 weeks

• Satisfaction with and benefits from the Intervention

  12 weeks and 24 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will receive a multi-component individualized support intervention "HEART", which will consist of 12 sessions in four stages.

Behavioral: HEART

Control group

ACTIVE COMPARATOR

Participants is the control group will be placed on a waiting list for 12 weeks. They will receive the intervention, after they complete the 12-week follow-up assessment. Caregivers in the control group will receive 12 week follow-up as usual (FU) including two brief "check-in" calls and an outcome measures call during the study period.

Other: Usual Care

Interventions

HEART BEHAVIORAL

The intervention group will receive a multi-component individualized support intervention "HEART", which will consist of 12 sessions in four stages. By using a comprehensive assessment targeting five components, an individualized intervention plan will be developed to address identified problems and unmet needs. Those five components consist of: Health, Emotion, Activities, Resources and Training.

Intervention group

Usual Care OTHER

Caregivers in the control group will receive 12 week follow-up as usual (FU) including two brief "check-in" calls and an outcome measures call during the study period.

Control group

Eligibility Criteria

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

You may qualify if:

• Primary caregivers being adult children (age 18 or older) who have spent at least 2 hours per day over the last 3 months caring for a parent with a diagnosis of dementia.
• Must have telephone access.
• Caregivers will not end their primary caregiving role within 6 months of study enrollment.

You may not qualify if:

• Cognitive impairment or intellectual disability.
• Those who are providing care for another relative with chronic physical or mental diseases.
• Pregnant women (Because it is unlikely that this group would be primary caregivers except in exceptional circumstances, the consideration of which was beyond the scope of this research).

Sponsors & Collaborators

• Yale University: lead

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, controlled trial (RCT) will be used to compare a 12-week intervention group with a waiting-list control group.

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 19, 2017
• Study Start: September 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 20, 2021

Record last verified: 2021-04