---
title: A Trial of a Multi-component Individualized Telephone-based Support Intervention for Adult-child Caregivers Caring for Parents With Dementia
nct_id: NCT03378050
overall_status: WITHDRAWN
phase: NA
sponsor: Yale University
study_type: INTERVENTIONAL
primary_condition: Dementia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03378050.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03378050"
ct_last_update_post_date: 2021-04-20
last_seen_at: "2026-05-12T06:51:44.070Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Trial of a Multi-component Individualized Telephone-based Support Intervention for Adult-child Caregivers Caring for Parents With Dementia

**Official Title:** Efficacy and Feasibility of a Multi-component Individualized Telephone-based Support Intervention for Adult-child Caregivers Caring for Parents With Dementia in China: Study Protocol of a Randomized Controlled Trial

**NCT ID:** [NCT03378050](https://clinicaltrials.gov/study/NCT03378050)

## Key Facts

- **Status:** WITHDRAWN
- **Why Stopped:** Study Never Began
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 0
- **Lead Sponsor:** Yale University
- **Conditions:** Dementia
- **Start Date:** 2018-09
- **Completion Date:** 2020-09
- **CT.gov Last Update:** 2021-04-20

## 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.

## Detailed Description

The objectives of this study are to evaluate the efficacy and feasibility of a multi-component individualized telephone-based support intervention (HEART) for adult-child caregivers caring for parents with dementia in China.

The primary hypothesis to test is whether the HEART is more efficacious in reducing caregiver burden than the follow-up as usual (FU) in dementia adult-child caregivers.

Secondary hypotheses include the following:

1. The HEART is more efficacious in improving health related quality of life than the FU in dementia adult-child caregivers.
2. The HEART is more efficacious in protecting reciprocal Filial Piety than the FU in dementia adult-child caregivers.
3. The HEART is more efficacious in relieving CR's behavioral and psychological symptoms of dementia (BPSD) than the FU in dementia adult-child caregivers.
4. The HEART group has a higher satisfaction with the intervention than the FU group.

In addition, two research questions will be answered by qualitative data from process evaluation for the feasibility of the HEART intervention. The research questions are as follows:

1. To what extent can the HEART intervention be delivered as planned?
2. What are the barriers to and facilitators of the HEART intervention?

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).
```

## Arms

- **Intervention group** (EXPERIMENTAL) — The intervention group will receive a multi-component individualized support intervention "HEART", which will consist of 12 sessions in four stages.
- **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.

## 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.
- **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.

## Primary Outcomes

- **Caregiver Burden** _(time frame: 12 weeks)_ — 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).

## Secondary Outcomes

- **Caregiver Burden** _(time frame: Baseline, 6 weeks and 24 weeks)_
- **Health Related Quality of Life** _(time frame: Baseline, 6 weeks, 12 weeks and 24 weeks)_
- **Reciprocal Filial Piety** _(time frame: Baseline, 6 weeks, 12 weeks and 24 weeks)_
- **BPSD** _(time frame: Baseline, 6 weeks, 12 weeks and 24 weeks)_
- **Satisfaction with and benefits from the Intervention** _(time frame: 12 weeks and 24 weeks)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

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*Canonical: https://parkinsonspathways.com/agent/trials/NCT03378050.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03378050*  
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