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IMPACT: Innovations using mHealth for people with dementia and comorbidities and their caregivers in Peru

IMPACT Dementia: Feasibility of an Intervention to Support People with Dementia and their Caregivers in Peru

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN37750099
Enrollment
96
Registered
2025-10-23
Start date
2025-10-20
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, hypertension and diabetes mellitus (common physical comorbidities among PwD) Mental and Behavioural Disorders

Interventions

Care Ecosystem (CE) Peru – Adapted Intervention A 9-month, telephone- and mHealth-based person-centred care navigation program for informal caregivers of PwD. The intervention provides structured cou

Sponsors

Imperial College London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: For People with Dementia (PwD): 1. Classified as a “dementia case” in WP2 of IMPACT (positive results on RUDAS-PE and CDR scales) or people with a clinical diagnosis of dementia issued by a healthcare professional in facilities previously contacted in each region. 2. Resides in the study city =6 months and plans to remain for 9 months. 3. Provides informed consent or assent (if possible), with legal representative consent from the caregiver when applicable. For Caregivers: 1. =18 years old. 2. Primary unpaid caregiver (family or close person). 3. In caregiving role =3 months (shorter periods accepted when roles recently changed). 4. Resides in the study city =6 months and plans to remain for 9 months. 5. Able to provide informed consent. 6. Has access to a mobile phone.

Exclusion criteria

Exclusion criteria: For caregivers: 1. Inability to communicate with study staff due to language or severe cognitive barriers. For PwD: 1. Active objection to participation or refusal to provide assent. General: 1. Any condition that, in the investigator’s opinion, prevents safe participation or comprehension of study procedures.

Design outcomes

Primary

MeasureTime frame
Feasibility outcomes measured using study records at one timepoint: 1. Recruitment rate (% dyads consenting out of those invited) 2. Retention rate at 4.5 and 9 months 3. Fidelity of intervention delivery (proportion of CTN calls and protocols completed as planned) 4. Engagement metrics (number of caregiver–CTN and caregiver–chatbot interactions) 5. Data completeness and usability of the digital platform for data collection

Secondary

MeasureTime frame
The following secondary outcome measures are assessed at baseline, 4.5 months and 9 months: Caregiver: 1. Burden measured using the Zarit Caregiver Burden Questionnaire 2. Depressive symptoms measured using the PHQ-9 3. Self-efficacy in caregiving measured using an ad-hoc CE questionnaire 4. Quality of life measured using the EuroQol EQ-5D-5L questionnaire Person with dementia (PwD): 1. Quality of life measured using the EuroQol EQ-5D-5L 2. Clinical measures assessed via blood pressure measured using a sphygmomanometer through a trained fieldworker and blood glucose through an external laboratory 3. Medication adherence measured using the Morisky Medication Adherence Scale (MMAS-4) 4. Use of emergency and hospital services measured using an ad-hoc questionnaire Economic: 1. Health resource utilization and implementation cost measured using economic cost measures through interviews at the end of the intervention

Countries

Peru

Contacts

Public ContactFrancisco Diez-Canseco Montero
francisco.diez.canseco.m@upch.pe+51 997912102

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026