CI-HI: The Cognitive Impairment Health Index
CI-HI: The Cognitive Impairment Health Index
- Type of Clinical Outcome Assessment (COA): Patient-reported outcome measure (PRO) and Caregiver or observer-reported outcome (CR/ObsRO)
- Administration Mode: Self-administered
- Therapeutic Area: Alzheimer’s disease, mild cognitive impairment (MCI), & dementia
- Approximate Completion Time: 5 minutes
- Required Supervision: None
- Recall Period: Immediate point in time
Instrument Variations
- The Cognitive Impairment Health Index Short Form (CI-HI-SF)
- CI-HI Short Form Completion Time: Under 1 minute
- The Cognitive Impairment Caregiver Reported Health Index (CICR-HI)
- CICR-HI Completion Time: 6 minutes (completed by a caregiver on behalf of a patient)
- The Cognitive Impairment Caregiver Reported Health Index Short Form (CICR-HI-SF)
- CICR-HI Short Form Completion Time: Under 1 minute (completed by a caregiver on behalf of a patient)
Symptom Subscales
- CI-HI Number of Independently Validated Symptom Subscales: 9
- CI-HI Symptom Subscales: Memory; Fatigue; Cognition; Sleep & Daytime Sleepiness; Social Satisfaction; Communication; Emotional Health; Activity Participation; Pain
- CICR-HI Number of Independently Validated Symptom Subscales: 8
- CICR-HI Symptom Subscales: Memory; Cognition; Social Satisfaction; Fatigue; Sleep & Daytime Sleepiness; Emotional Health; Activity Participation; Communication
Instrument Attributes
- The CI-HI is a patient-reported outcome (PRO) measure designed to assess symptoms and health-related quality-of-life from the perspective of patients with Alzheimer’s disease, mild cognitive impairment, or dementia.
- Designed and validated to fully satisfy regulatory and published FDA guidance for use in drug-labeling claims and measuring changes in how a patient feels and functions.
- The CI-HI is highly relevant to patients, has low patient burden, correlates with markers of disease severity, and demonstrates low floor and no ceiling effects.
- The CI-HI is a fully valid, reliable, responsive, and disease-specific instrument capable of measuring changes in patient-reported health in patients with Alzheimer’s disease, mild cognitive impairment, or dementia in response to therapeutic intervention during clinical trials or clinical monitoring.
- The CI-HI was developed using extensive patient and caregiver input, including an analysis of 1,166 patient quotes and a large cross-sectional study involving 104 patients.
- The CICR-HI measures issues that are highly relevant to patients from the perspective of the caregiver, has low participant burden, correlates with markers of disease severity, and demonstrates no floor or ceiling effects.
- The CICR-HI is a caregiver-reported outcome (CRO/ObsRO) measures designed to assess symptoms and health-related quality-of-life of a patient with Alzheimer’s disease, mild cognitive impairment (MCI), or dementia.
- The CICR-HI was developed using extensive caregiver input, including an analysis of 1,097 caregiver quotes and a large cross-sectional study involving 329 caregivers. The CICR-HI measures issues and symptoms that are highly relevant to patients and is easy to complete.
- English
Additional translations available upon request.
Pending
- “The Alzheimer’s Disease-Health Indices (AD-HI): Development of Two Novel Outcome Measures for Use in Clinical Trials.” J. Seabury, A. Arky, M. Ayles, N. Dilek, M. Hance, S. Rosero, E. Santos, J. Weinstein, A. Varma, C. Heatwole. Alzheimer’s Association International Conference. San Diego, CA. 7/31/22.
- “Development of a patient-reported outcome measure for Alzheimer’s disease: the Alzheimer’s Disease-Health Index (AD-HI), a fully validated tool to bolster clinical trial and research infrastructure.” S. Rosero, A. Varma, J. Seabury, J. Weinstein, C. Engebrecht, N. Dilek, A. Arky, E. Santos, C. Heatwole. The Alzheimer’s Disease International Conference. Amsterdam, Netherlands. 7/2023.
- “Development and validation of a caregiver-reported outcome measure for Alzheimer’s disease: the Alzheimer’s Disease Caregiver Reported-Health Index (ADCR-HI), a fully validated tool to bolster clinical trial and research infrastructure”. S. Rosero, A. Varma, J. Seabury, J. Weinstein, C. Engebrecht, N. Dilek, A. Arky, E. Santos, C. Heatwole. The Alzheimer’s Disease International Conference; July 16-20, 2023; Amsterdam, Netherlands.
- “The Alzheimer’s Disease-Health Index (AD-HI): a novel, disease-specific, patient-reported outcome measure for use in Alzheimer’s disease clinical trials and patient monitoring”. C. Engebrecht, J. Seabury, A. Varma, J. Weinstein, S. Rosero, C. Shupe, C. Irwin, N. Dilek, A. Arky, E. Santos, C. Heatwole. The Alzheimer’s Association International Conference; July 28-August 1, 2024; Philadelphia, PA.
- “The development and validation of the Alzheimer’s Disease Caregiver Reported – Health Index (ADCR-HI): A disease-specific caregiver-reported outcome measure for use in clinical trials”. C. Shupe, J. Seabury, A. Varma, J. Weinstein, C. Engebrecht, S. Rosero, C. Irwin, N. Dilek, A. Arky, E. Santos, C. Heatwole. The Alzheimer’s Association International Conference; July 28-August 1, 2024; Philadelphia, PA.
Instrument Scoring
All subscales are scored on a scale of 0 to 100 with 0 representing no disease burden and 100 representing the maximum level of disease burden. Symptom questions within each subscale are weighted based on participant-reported prevalence and average impact as identified through the cross-sectional study. Subscale scores are also weighted to generate a total CI-HI or CICR-HI score (0-100) representing overall disease burden.