Clinical trial NCT04083456: Dysvascular Amputation Self-Management of Health
Official title: Improving Health Self-Management Using Walking Biobehavioral Intervention for People With Dysvascular Lower Limb Amputation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Amputation
Diabetes Mellitus
Peripheral Artery Disease
Keywords: Amputation
Dysvascular Amputation
Diabetes
Peripheral Artery Disease
Physical Activity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-09-10
Enrollment: 64
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled futility design
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if walking biobehavioral intervention improves physical activity after dysvascular lower limb amputation.

Detailed description: Sedentary lifestyles and high levels of disability are relevant public and personal health issues resulting from the chronic comorbid condition of dysvascular lower limb amputation. This study examines the use of an evidence-based walking biobehavioral intervention to increase physical activity after dysvascular amputation. The proposed intervention leverages successes in conventional prosthetic rehabilitation, while addressing the complex health conditions and chronic sedentary behaviors that underlie dysvascular amputation, with the ultimate goal of improved physical activity self-management to minimize disability.

Eligibility criteria: Inclusion Criteria:

* Within the age range of 50-85 years
* Confirmed diagnosis of Type II Diabetes Mellitus (DM) and/or Peripheral Artery Disease (PAD)
* Transtibial, knee disarticulation, or transfemoral lower-limb amputation (LLA) (or re-amputation) within the past 12 months
* Participant goal of household walking or better using a prosthesis

Exclusion Criteria:

* Trauma or cancer-related etiology of the LLA
* Decisionally challenged individuals (MMSE score below 24)
* Prisoners
* Active cancer treatment
* Recent stroke (within 2 years)
* Clinical discretion of principal investigator to exclude patients who are determined to be unsafe and/or inappropriate to participate in the described intervention.

Primary outcomes:
measure: Physical Activity
timeFrame: Day 0 (start of conventional prosthetic rehabilitation), prosthetic rehabilitation end (3 months), intervention end (6 months), and 6 months after intervention end (12 months)
Secondary outcomes:
measure: Patient Reported Outcomes Measurement Information System (PROMIS): Self-Efficacy for Managing Symptoms
timeFrame: Day 0, 3 months, 6 months and 12 months
measure: PROMIS: Self-Efficacy for Managing Daily Activities
timeFrame: Day 0, 3 months, 6 months and 12 months
measure: PROMIS: Ability to participate in social roles and activities
timeFrame: Day 0, 3 months, 6 months and 12 months
measure: Prosthesis Evaluation Questionnaire - Mobility Score
timeFrame: Day 0, 3 months, 6 months and 12 months
measure: Timed Up-and-Go test
timeFrame: Day 0, 3 months, 6 months and 12 months
measure: World Health Organization-Disability Assessment Schedule 2.0
timeFrame: Day 0, 3 months, 6 months and 12 months
measure: Self-Efficacy for Managing Chronic Disease
timeFrame: Day 0, 3 months, 6 months and 12 months
Other outcomes:
measure: Activities-specific Balance Confidence Scale
timeFrame: Day 0, 3 months, 6 months and 12 months
measure: Two-Minute Walk Test
timeFrame: Day 0, 3 months, 6 months and 12 months
measure: Five Meter Walk
timeFrame: Day 0, 3 months, 6 months and 12 months
measure: Study Intervention Reach
timeFrame: Day 0
measure: Outpatient Practitioner Intervention Fidelity
timeFrame: Day 0 through 3 months
measure: Biobehavioral Practitioner Intervention Fidelity
timeFrame: Day 0 through 6 months
measure: FitBit Use Adherence
timeFrame: Month 12
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Cory Christiansen, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: