Pilot Mobile for Dementia and Frailty

Phase 1

Completed

• Conditions: Dementia; Frailty
• Interventions: Other: Usual Care; Other: Mobile app

• Registration Number: NCT05827094
• Lead Sponsor: University of Washington

Brief Summary

In this project, we propose to build on our Stage I formative work (according to the NIH Stage Model for Behavioral Intervention Development), where we developed fully functional prototypes of a mobile intervention aimed at improving adherence to Mediterranean Diet (MedD) for older adults with frailty and early dementia to complete the Stage II exploratory work, where the intervention will undergo further feasibility, acceptability, and preliminary efficacy tests. The intervention includes a patient-facing app that allows users to track their diet and receive personalized feedback concerning opportunities for improvement and recipes for breakfast, lunch, dinner, and snacks, informational materials about MedD, and a chat feature. On the other end, a web-based provider interface allows clinicians to review patient progress, suggest meal plans, and send and receive messages. The pilot randomized controlled trial, conducted over three months, will compare usual care to usual care plus mobile intervention to gather preliminary efficacy data concerning a change in adherence to MedD score (primary outcome). Mechanistic and secondary outcomes will include MedD knowledge, constructs from Social Cognitive Theory (self-efficacy, outcome expectation, self-regulation, and social support), platform use, anthropometric, and functional measures. Feasibility will be evaluated in terms of recruitment and retention outcomes. Acceptability will be determined through post-intervention semi-structured interviews and structured survey measures.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-12
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-24
• Study Start: 2023-06-06
• Primary Completion: 2024-03-15
• Study Completion: 2024-03-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

1. 65 years or older;
2. ICD-9-CM (ICD-10-CM) codes for mild or major neurocognitive disorders with mild-to-moderate severity due to several possible etiologies. Specifically, a) mild neurocognitive disorder 331.83 (G31.84); major neurocognitive disorder 294.1x (F02.8x) due to Alzheimer disease 331.0 (G30.9); frontotemporal lobar degeneration 331.19 (G31.09); Lewy body disease 331.82 (G31.83);
3. mild-to-moderate frailty
4. own a mobile device.

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Exclusion Criteria

1. Severe sensory impairment that makes it impossible to operate a mobile device or respond to prompts
2. English reading level below 6th grade
3. no care partner
4. optimal diet

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Participants randomly allocated to the control group will receive educational materials on healthy eating, as provided on the NIA web page (https://www.nia.nih.gov/health/healthy-eating).
Mobile Intervnetion	Mobile app	Participants randomized to the intervention arm will receive verbal and written instructions as well as one-on-one demonstration of the app features. Participants will have an option of either receiving the study mobile device or will be able to use their own device with an installed app. Following the training, participants will be asked to use the app at least once a week.

Primary Outcome Measures

Name	Time	Method
Adherence to Mediterranean Diet (aMed) score	Baseline; 12 weeks	MedD adherence outcomes will be measured using the FFQ and adherence to MedD (aMED) score

Secondary Outcome Measures

Name	Time	Method
Mediterranean Diet Nutrition Knowledge (MDNK) Questionnaire	Baseline; 12 weeks	Items include questions focused on knowledge about foods and nutrients that are important in the MedD.
Social Cognitive Theory	Baseline; 12 weeks	Social-cognitive theory (SCT) mechanistic variables will be measured using the Food Beliefs Survey and modified to focus on MedD
Short Physical Performance Battery	Baseline; 12 weeks	The Short Physical Performance Battery (SPPB) is designed to measure functional status and physical performance. The scale is a composite measure assessing walking speed, standing balance, and sit-to-stand performance. The three tests are summed to give a total score, with a maximum of 12 and a minimum of 0, with a higher score indicating higher function.
Body Mass Index	Baseline; 12 weeks	Weight to the nearest 0.1 kg and height to the nearest 0.1 cm will be measured and used to compute BMI.
Waist Circumference (WC)	Baseline; 12 weeks	WC at the natural waist or narrowest part of the torso will also be measured to the nearest 0.1 cm

Trial Locations

Locations (1)

Univeristy of Washington; 🇺🇸 Seattle, Washington, United States