Health TrialsbyHealthPanel

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

ConditionsDepression, UnipolarFall
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-100
SponsorUniversity of Texas at Austin

About this trial

This study will test clinical and cost effectiveness of an integrated tele- and bachelor's-level counselor/coach delivered behavioral activation (BA) and fall prevention (FP) for low-income homebound older adults. The long-term objective of the proposed study is to improve access to depression treatment and fall prevention for growing numbers of low-income homebound seniors. We plan to recruit 320 low-income, racially diverse homebound seniors who are served by a home-delivered meal (HDM) program and other aging-service agencies in Central Texas. In a 4-arm, pragmatic clinical trial with randomization prior to consent, the participants in the integrated Tele-BA and FP (TBF hereafter) arm will receive 5 Tele-BA sessions and 4 in-home FP sessions. Those in the Tele-BA or FP alone arms will receive the respective intervention and 4 bimonthly telephone check-in (booster) calls, and those in the Attention Control (AC) arm will receive 5 weekly telephone check-in calls followed by 4 bimonthly follow-up calls. Follow-up assessments will be at 12, 24, and 36 weeks after baseline.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 50+

English or Spanish proficiency

24-item Hamilton Rating Scale for Depression score > 15

12-item Fall Risk Questionnaire score >4

Disqualifiers

Recently (< 4 weeks) initiated or modified antidepressant pharmacotherapy

High suicide risk

Probable dementia

Bipolar disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Behavioral Activation

    Behavioral

    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.

  • Fall Prevention

    Behavioral

    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.

  • Telephone support

    Other intervention

    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.

Treatment groups

320 Participants
are divided into 4 treatment groups
Group A: Tele-Behavioral Activation and Fall PreventionExperimental treatment 2 interventions
Group B: Tele-Behavioral ActivationExperimental treatment 1 intervention
Group C: Fall PreventionExperimental treatment 1 intervention
Group D: Attention Control (Telephone Support Call)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
at 12, 24, and 36 weeks after baseline
2

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

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

Time frame
monthly (form 12 weeks to 36 weeks)
3

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

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

Time frame
at 12, 24, and 36 weeks after baseline
4

Changes from baseline physical and mental health service use

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

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

Secondary outcomes

1

Changes from baseline fear of falling at 12, 24, and 36 weeks

Changes in 7-item Falls Efficacy Scale International score (score range: 7-28; decreased score since baseline is a positive outcome)

Time frame
at 12, 24, and 36 weeks after baseline
2

Changes from baseline exercise frequency at 12, 24, and 36 weeks

Changes in RAPA (Rapid Assessment of Physical Activities) (score range: 1-9; increased score since baseline is a positive outcome)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas at Austin

Lead sponsor

Baylor College of Medicine

Collaborator

Source ClinicalTrials.gov
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