Trial results for a study on negotiation training for caregivers of patients with Alzheimer's Disease and Cognitive Impairment were posted on ClinicalTrials.gov on 2025-08-01, involving 132 participants.
Background
Alzheimer's Disease and cognitive impairment present significant challenges not only for patients but also for their family caregivers. These caregivers often face communication difficulties and conflicts in their roles, which can impact their well-being. Interventions aimed at improving caregiver communication and conflict resolution are important to support those providing care for individuals with these conditions. This study explored a negotiation and dispute resolution training intervention designed to address these specific challenges.
Trial design
This completed study, designated as Phase NA, enrolled 132 participants with conditions including Alzheimer Disease and Cognitive Impairment. The trial's purpose was to design a Negotiation and Dispute Resolution (NDR) training intervention to improve communication and address conflict resolution frequently experienced by family caregivers. The study evaluated the effect of this training on the "Change in Neuro-QoL Positive Affect and Well-Being Score" across various caregiver groups, including "Universal Only", "Older Adult", "Physician", "Physician/OA", "Sister", "Sister/OA", "Sister/Physician", and "Sister/Physician/OA".
Key results
The trial reported measurements for the "Change in Neuro-QoL Positive Affect and Well-Being Score" across different caregiver groups:
- For the "Universal Only" group, the mean score was 55.41 (Standard Deviation 4.07 T-Score) and 54.39 (Standard Deviation 5.59 T-Score).
- For the "Older Adult" group, the mean score was 56.22 (Standard Deviation 6.94 T-Score) and 55.74 (Standard Deviation 4.82 T-Score).
- For the "Physician" group, the mean score was 55.51 (Standard Deviation 6.84 T-Score) and 53.66 (Standard Deviation 6.22 T-Score).
- For the "Physician/OA" group, the mean score was 56.83 (Standard Deviation 7.23 T-Score) and 53.76 (Standard Deviation 6.84 T-Score).
- For the "Sister" group, the mean score was 54.2 (Standard Deviation 5.87 T-Score).
- For the "Sister/OA" group, the mean score was 52.83 (Standard Deviation 5.66 T-Score).
- For the "Sister/Physician" group, the mean score was 54.86 (Standard Deviation 4.84 T-Score).
- For the "Sister/Physician/OA" group, the mean score was 53.9 (Standard Deviation 5.92 T-Score).
Key analyses using a Mixed Models Analysis for "Mean Difference (Final Values)" on the "Change in Neuro-QoL Positive Affect and Well-Being Score" indicated:
- For the "physician" treatment arm, a mean difference of 0.1491 (95.0% CI: -0.856 to 1.15) with a p-value of 0.7695.
- For the "sister" treatment arm, a mean difference of -0.87 (95.0% CI: -1.88 to 0.13) with a p-value of 0.0878.
- For the "sister/physician" treatment arm, a mean difference of 0.2414 (95.0% CI: -0.76 to 1.25) with a p-value of 0.635.
- For the "older adult" treatment arm, a mean difference of -0.06574 (95.0% CI: -1.0709 to 0.9394) with a p-value of 0.897.
- For the "physician/older adult" treatment arm, a mean difference of -0.01126 (95.0% CI: -1.0164 to 0.9939) with a p-value of 0.9823.
- For the "sister/older adult" treatment arm, a mean difference of -0.4928 (95.0% CI: -1.4979 to 0.5124) with a p-value of 0.3337.
What this means
The analyses of the negotiation training intervention for Alzheimer's and cognitive impairment caregivers did not demonstrate a statistically significant improvement in the "Change in Neuro-QoL Positive Affect and Well-Being Score" across the various treatment arms. All reported p-values were above the conventional threshold for statistical significance (e.g., 0.05), with the lowest being 0.0878 for the "sister" treatment arm. This indicates that while the intervention addressed important aspects of caregiver communication and conflict resolution, a measurable positive impact on caregiver well-being, as assessed by this specific outcome, was not statistically confirmed in this study.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04837937, titled "Negotiation Training for Caregiver Communication in AD", were posted on 2025-08-01 on clinicaltrials.gov.