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Behavioral Intervention

mPATH for Cognitive Impairment and Insomnia

N/A

Recruiting

Led By Junxin Li

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Must not have

History of neurologic or psychiatric disorders, neurodevelopmental impairment, traumatic brain injury

Untreated sleep apnea

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months, 12 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test if a mobile health program can help improve the thinking skills and sleep of older adults with low income."

Who is the study for?

This trial is for low-income older adults who have trouble sleeping, lead a sedentary lifestyle without much exercise, and can do moderate intensity workouts. It's not suitable for those who don't meet the income criteria or cannot safely engage in physical activity.

What is being tested?

The study tests an mHealth-facilitated program called mPATH designed to improve sleep and cognitive function through increased physical activity. Participants will either receive this intervention or be part of an attention control group for comparison.

What are the potential side effects?

Since the intervention involves physical activity, potential side effects may include typical exercise-related discomforts such as muscle soreness or fatigue. However, specific side effects will depend on individual health conditions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of brain injury or mental health disorders.

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I have sleep apnea that has not been treated.

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I have severe depression or anxiety.

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I have been diagnosed with dementia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in episodic memory as assessed by the Cogstate Alzheimer's Battery

Secondary study objectives

Change in Sleep efficiency as assessed by actigraphy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: mPATHExperimental Treatment1 Intervention

mPATH is a personalized physical activity intervention that includes personalized physical activity plans and training sessions, exercise at home by following personalized exercise videos, and biweekly phone coaching over 24 weeks, supported by wearable devices-enabled mHealth strategies. mHealth strategies and exercise videos will be used to support participant's physical activity during 6-12months

Group II: Education and Social controlActive Control1 Intervention

This attention control group is designed to match the intervention for mPATH's staff-subject interaction duration through monthly home visits in the first 6 months

0 / 4Eligibility criteria met