Integrated Tele-Behavioral Activation and Fall Prevention for Low-income Homebound Seniors With Depression

BEHAVIORAL

Behavioral Activation

In BA, depressive symptoms are viewed as depressive behaviors. Compared to those without depression, people with depression engage in fewer overt behaviors that provide positive reinforcement and pleasure/enjoyment and in more behaviors that function to escape or avoid aversive stimuli (e.g., staying in bed all day).55-59 Thus, BA is aimed at increasing and reinforcing meaningful, healthy, and enjoyable behaviors while decreasing depressive behaviors and is well-suited to help depressed, disabled older adults increase mood-enhancing activities, self-care management skills, and social connectedness.

BEHAVIORAL

Fall Prevention

Following FP psychoeducation based on the Centers for Disease Control and Prevention (CDC)'s STEADI tool kits, lay coaches will assist clients in implementing evidence-based FP strategies that have been adapted for low-income homebound seniors. These include referrals to healthcare providers as needed, home safety checks, practice of safe ambulation/transfer and mobility aid use, medication review, and in-home exercise routines with an innovative, gamified tablet-based exercise app for balance and strength building.

OTHER

Telephone support

Subjects in this arm will receive 9 weekly support calls last 30 minutes each. These calls are intended to provide an opportunity for social support and check safety.

Changes from baseline depressive symptom at 12, 24, and 36 weeks

Time frame: at 12, 24, and 36 weeks after baseline

24-item Hamilton Rating Scale for Depression score (score range: 15-40; decreased score since baseline is a positive outcome)

Changes from baseline fall count and injury at 12, 24, and 36 weeks

Time frame: monthly (form 12 weeks to 36 weeks)

Changes in six monthly falls calendar data (reduced number of falls since baseline is a positive outcome)

Changes from baseline EuroQol-5D score at 12, 24, and 36 weeks

Time frame: at 12, 24, and 36 weeks after baseline

Cost-effectiveness measure (score range: 0-20; decreased score since baseline is a positive outcome)

Changes from baseline physical and mental health service use

Time frame: at 12, 24, and 36 weeks after baseline

Changes in Cornell Services index data (decreased ED visits and hospitalization since baseline is a positive outcome)

Changes from baseline disability score at 12, 24, and 36 weeks

Time frame: at 12, 24, and 36 weeks after baseline

Changes in 12-item World Health Organization Disability Assessment Schedule score (score range: 0-46; decreased score since baseline is a positive outcome)

Changes from baseline social engagement and activities score at 12, 24, and 36 weeks

Time frame: at 12, 24, and 36 weeks after baseline

Changes in 10-item Social Engagement and Activities Questionnaire score (score range: 0-50; increased score since baseline is a positive outcome)

Changes from baseline satisfaction with social roles & activities at 12, 24, and 36 weeks

Time frame: at 12, 24, and 36 weeks after baseline

C (score range: 0-32; increased score since baseline is a positive outcome)

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.