---
title: Impact of Formal Home Help on Quality of Life for Caregivers of Elderly Patients With Neurocognitive Impairment
nct_id: NCT04732312
overall_status: TERMINATED
sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
study_type: OBSERVATIONAL
primary_condition: Age-related Cognitive Decline
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04732312.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04732312"
ct_last_update_post_date: 2025-11-20
last_seen_at: "2026-05-12T07:16:08.714Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Impact of Formal Home Help on Quality of Life for Caregivers of Elderly Patients With Neurocognitive Impairment

**Official Title:** Impact of Formal Home Help on Quality of Life for Caregivers of Elderly Patients With Neurocognitive Impairment: a Prospective Monocenter Study

**NCT ID:** [NCT04732312](https://clinicaltrials.gov/study/NCT04732312)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** recruitment issues
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 12
- **Lead Sponsor:** Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
- **Conditions:** Age-related Cognitive Decline
- **Start Date:** 2019-03-19
- **Completion Date:** 2019-10-16
- **CT.gov Last Update:** 2025-11-20

## Brief Summary

The purpose of this prospective monocenter observational study is to assess the impact of the first introduction of formal home help (personalized autonomy allowance for seniors) on the quality of life of home caregivers of elderly patients with neurocognitive impairment.

## Detailed Description

An aging population is leading to an increase in neurodegenerative disorders that are responsible for loss of autonomy. In order to keep patients with neurocognitive impairment at home, the availability of home caregivers is essential. The neurocognitive deterioration of elderly patients is a significant burden for home caregivers and can affect their quality of life. The implementation of formal home help (personalized autonomy allowance for seniors) can relieve home caregivers and improve their quality of life.

Conduct of research:

Elderly patients followed in the geriatric department of the Mulhouse French hospital, and for whom a formal home help (personalized autonomy allowance for seniors) is initiated will be recruited. The evolution of home caregiver's quality of life, burden and vulnerability, will be assessed during three months.

## Eligibility

- **Minimum age:** 60 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion criteria:

* Patient 60 years of age or older
* Diagnosis of neurocognitive disorders
* MMSE score less than or equal to 26
* GIR score inferior or equal to 4
* Introduction of formal home help (personalized autonomy allowance for seniors program)
* Patient living in Haut-Rhin department (France)
* Patient receiving regular informal help at home (at least once a week)
* Availability of the current home helper to participate in the sudy
* Non-opposition to participation in the study

Exclusion criteria:

* Introduction of formal home care not related to the personalized autonomy allowance program
* Patient under legal protection
```

## Interventions

- **Home help** (OTHER) — Setting up of a formal home help

## Primary Outcomes

- **Caregiver quality of life** _(time frame: 90 days)_ — Variation of caregiver quality of life between inclusion and 90 days. Quality of life is assessed with the PIXEL study evaluation scale. This is a 20-item scale, subdivided in four domains: behavioral capacities to face difficulties generated by the patient, relation with the environment, psychological perception of the situation, perception of a possible distress. Score ranges from 0 to 100 points (5 points for each item).

## Secondary Outcomes

- **Caregiver vulnerability** _(time frame: 90 days)_
- **Caregiver burden** _(time frame: 90 days)_
- **Caregiver quality of life according to the type of formal home care** _(time frame: 90 days)_
- **Caregiver vulnerability according to the type of formal home care** _(time frame: 90 days)_
- **Caregiver burden according to the type of formal home care** _(time frame: 90 days)_
- **Variation of quality of life score according to each domain** _(time frame: 90 days)_
- **Description of the aids set up within the framework of the personalized autonomy allowance for seniors program.** _(time frame: 90 days)_

## Locations (1)

- GHRMSA, Mulhouse, Haut-Rhin, France

## Recent Field Changes (last 30 days)

- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — 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.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ghrmsa|mulhouse|haut-rhin|france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04732312.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04732312*  
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