Collaborative-care Rehabilitation After Dysvascular Amputation

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Diabetes Complications; Peripheral Arterial Disease

Treatments: Behavioral: Health Self-Management Support; Behavioral: Walking Program; Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01929018

13-0179

Details and patient eligibility

About

The objective of this study is to examine the feasibility of using a collaborative-care, home-based rehabilitation program to improve functional outcomes for people recovering from lower limb amputation caused by vascular problems and/or diabetes complications. The primary hypothesis is that the rehabilitation program will result in greater improvements in performance-based and participant-reported measures of physical function, compared to standard of care after outpatient rehabilitation.

Enrollment: 38 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diabetes and/or Peripheral Artery Disease
2. Unilateral transtibial amputation < 6 months prior to screening
3. Household ambulation using definitive prosthesis prior to baseline testing
4. Participation in physical rehabilitation at time of baseline testing
5. Live within 45 minutes of a participating clinic

Exclusion criteria

1. Require wheelchair for mobility (use prosthesis for transfers only)
2. Ankle-level or above amputation on contralateral limb
3. Traumatic or cancer-related amputation
4. Uncontrolled heart condition
5. Acute systemic infection
6. Pregnancy
7. Decisionally challenged
8. Prisoners

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Exercise, activity, and self-management

Experimental group

Description:

Exercise, Walking Program, and Health Self-Management Support. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to deliver the interventions.

Treatment:

Behavioral: Walking Program

Behavioral: Exercise

Behavioral: Health Self-Management Support

Home and phone visit

No Intervention group

Description:

No intervention will be applied. Participants will be visited at home once monthly and contacted by phone once weekly over 12 weeks to monitor health status.