Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dysvascular Amputation Self-Management of Health (DASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04083456
Recruitment Status : Active, not recruiting
First Posted : September 10, 2019
Last Update Posted : April 17, 2020
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of Colorado, Denver

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

Condition or disease Intervention/treatment Phase
Amputation Diabetes Mellitus Peripheral Artery Disease Behavioral: Walking Biobehavioral Intervention Other: Attention Control Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled futility design
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Improving Health Self-Management Using Walking Biobehavioral Intervention for People With Dysvascular Lower Limb Amputation
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : May 31, 2024

Arm Intervention/treatment
Experimental: Walking Biobehavioral Intervention (EXP)
The EXP group will receive biobehavioral training that is integrated into the conventional outpatient training component and is delivered over 5 months. There will be 10 biobehavioral sessions, 1 of which will be a combined biobehavioral/conventional outpatient session and the other 9 being telehealth sessions.
Behavioral: Walking Biobehavioral Intervention
Each walking biobehavioral training session includes self-monitoring, tailored feedback, identification of barriers and facilitators, problem solving, action planning and encouragement. Self-monitoring of walking behavior will occur with participant use of the FitBit sensor and software, reviewed with the interventionist at each session. Tailored feedback from the FitBit sensor, as well as feedback from the interventionist, will detail progress over time and be compared to baseline data. Barriers and facilitators of reaching activity goals will be discussed with emphasis on problem solving to take advantage of facilitators and minimize/remove participant-specific barriers. Action planning will be based on weekly step goals set collaboratively by the interventionist and participant, based the FitBit data. Finally, encouragement will be provided by the interventionist by putting progress or lack of progress in perspective of the efforts made by the participant.

Active Comparator: Attention Control (CTL)
The CTL group intervention will include the same conventional outpatient training (10 sessions) as the EXP group and receive the same computer tablets with telehealth software as the EXP group (week 3 of prosthetic training).
Other: Attention Control
Attention control sessions will include a brief review of the conventional home-exercises, a summary of all healthcare visits and falls, and interventionist-delivered education on safety topics (e.g., fall prevention, wound care, assistive device use). Outpatient therapists will provide home-based exercises to ensure that the participant receives adequate training and demonstrates safe performance prior to home use. The CTL interventionist will assess and discuss the safe performance of each home-based exercise with CTL group participants. Exercises in the CTL group will only be progressed by the outpatient physical therapist and not during the telehealth sessions.




Primary Outcome Measures :
  1. Physical Activity [ Time Frame: Day 0 (start of conventional prosthetic rehabilitation), prosthetic rehabilitation end (3 months), intervention end (6 months), and 6 months after intervention end (12 months) ]
    Change in 10 day physical activity step count with ActivPAL activity monitor between the beginning of conventional prosthetic rehabilitation to the end of intervention. Maintenance will be observed at six months after the end of the intervention.


Secondary Outcome Measures :
  1. Patient Reported Outcomes Measurement Information System (PROMIS): Self-Efficacy for Managing Symptoms [ Time Frame: Day 0, 3 months, 6 months and 12 months ]
    Change in participant's confidence in managing symptoms of chronic disease. Final scores range from 4 points (not at all confident) to 20 points (very confident).

  2. PROMIS: Self-Efficacy for Managing Daily Activities [ Time Frame: Day 0, 3 months, 6 months and 12 months ]
    Change in participant's confidence in managing daily activities. Final scores range from 4 points (not at all confident) to 20 points (very confident).

  3. PROMIS: Ability to participate in social roles and activities [ Time Frame: Day 0, 3 months, 6 months and 12 months ]
    Change in participant's ability to participate in social roles and activities. Final scores range from 8 points (never participates) to 40 points (always participates).

  4. Prosthesis Evaluation Questionnaire - Mobility Score [ Time Frame: Day 0, 3 months, 6 months and 12 months ]
    Change in self-reported mobility. Final scores range from 0 (lowest mobility) to 4 (highest mobility)

  5. Timed Up-and-Go test [ Time Frame: Day 0, 3 months, 6 months and 12 months ]
    Change in time required to rise from chair, walk 10 feet, turn around and return to sitting in same chair.

  6. World Health Organization-Disability Assessment Schedule 2.0 [ Time Frame: Day 0, 3 months, 6 months and 12 months ]
    Change in self-reported disability. Final scores range from 0 (no disability) to 100 (full disability).

  7. Self-Efficacy for Managing Chronic Disease [ Time Frame: Day 0, 3 months, 6 months and 12 months ]
    Change in self-reported confidence in managing different aspects of chronic disease. Final scores range from 1 (not at all confident in managing chronic disease) to 10 (totally confident in managing chronic disease).


Other Outcome Measures:
  1. Activities-specific Balance Confidence Scale [ Time Frame: Day 0, 3 months, 6 months and 12 months ]
    Change in self-reported balance confidence. Final scores range from 0% (no confidence in balance) to 100% (complete confidence in balance).

  2. Two-Minute Walk Test [ Time Frame: Day 0, 3 months, 6 months and 12 months ]
    Change in the distance a participant can walk in two minutes. Use of assistive device is noted

  3. Five Meter Walk [ Time Frame: Day 0, 3 months, 6 months and 12 months ]
    Change in the length of time it takes a participant to walk 5 meters, at a comfortable walking pace.

  4. Study Intervention Reach [ Time Frame: Day 0 ]
    Percentage of eligible participants enrolled

  5. Outpatient Practitioner Intervention Fidelity [ Time Frame: Day 0 through 3 months ]
    An individual practitioner's percent adherence to outpatient intervention protocol

  6. Biobehavioral Practitioner Intervention Fidelity [ Time Frame: Day 0 through 6 months ]
    An individual interventionist's percent adherence to biobehavioral intervention protocol

  7. FitBit Use Adherence [ Time Frame: Month 12 ]
    Number of days participant uses FitBit during the no-contact phase of the study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083456


Locations
Layout table for location information
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Nursing Research (NINR)
Investigators
Layout table for investigator information
Principal Investigator: Cory Christiansen, PT, PhD University of Colorado, Denver
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04083456    
Other Study ID Numbers: 19-0534
R01NR018450 ( U.S. NIH Grant/Contract )
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will publish the trial results data on the ClinicalTrials.gov website, on which the clinical trial will be registered. Sharing of data will include the potential of sharing raw data generated from all clinical assessments under a data-sharing agreement.
Supporting Materials: Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: We will publish the trial results within one year of testing the final participant.
Access Criteria: User registration will be required to access/download any data and will require agreement to conditions of use in accordance with NIH Data Sharing Policy Guidelines.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Amputation
Dysvascular Amputation
Diabetes
Peripheral Artery Disease
Physical Activity
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases