Remote Assessment of Physical Function

NCT04339959 | Completed Results

• 2 other identifiers: UNM HSC IRB 17-334K07CA215937-02
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to evaluate the validity and reliability of using videoconferencing to assess physical performance tests self-administered by older cancer survivors in their own homes. This remote assessment will be compared to the traditional face-to-face (i.e., in-person) assessment and to accelerometer data.

Conditions

Cancer Survivors

Keywords

physical function; physical performance; video conferencing

Outcome Measures

Primary Outcomes (2)

• Validation - 30-second Chair Stand Test

  Comparison of remote assessment to the traditional face-to-face (i.e., in-person; direct observer) assessment. Phase 2 will enroll 10-20 participants, depending on the point at which no new information is learned about the use of the toolkit (including instructions). Comparisons will be made between the direct observer and the remote assessor. The 30-second chair stand test involves standing up from a chair and sitting down as quickly and safely as possible, preferably without the use of upper extremity support. It is measured by the number of times a person comes to a full standing position from a chair in 30 seconds. The outcome is the difference in the number of chair stands counted between the direct observer and the remote assessor.

  1 day

• Validation - Timed Up & Go Test

  Comparison of remote assessment to the traditional face-to-face (i.e., in-person; direct observer) assessment. Phase 2 will enroll 10-20 participants, depending on the point at which no new information is learned about the use of the toolkit (including instructions). The Timed Up \& Go test involves standing up from a standard armchair, walking 10 feet, turning around (180° turn), and walking back to the chair and sitting down. Comparisons will be made between the direct observer and the remote assessor. The outcome is the difference in the number of seconds counted between the direct observer and the remote assessor.

  1 day

Secondary Outcomes (1)

• Reliability - Percentage of Participants Who Successfully Completed the Revised Protocol.

  3 months

Study Arms (4)

Phase I

First, we will test proof-of-concept that participants will be able to follow the testing protocol and use the tablet computer to communicate with the investigator (10-12 participants). The test protocol will be refined based on what is learned after a minimum of 10 participants. We anticipate no more than 12 participants needed for this phase.

Other: Remote Assessment of Physical Function with Direct Observation

Phase II

Next, 10-20 new participants will be enrolled to evaluate the validity of videoconference vs. face-to-face assessment (i.e., direct observation) of physical performance. Communication will occur between the remote assessor and the participant. The direct observer will not communicate directly to the participant, unless there is a safety issue. After completing 10 participants without a major change in the test protocol, we will proceed to the next phase.

Other: Remote Assessment of Physical Function with Direct Observation

Phase III

This phase involves participants repeating the test protocol, but without the face-to-face assessment (i.e., direct observation). This will test the ability of the participant to receive the box of test instructions and materials in the mail, unpack the box, communicate with the remote assessor via videoconferencing, pack up the box, and return it (postage paid) to the study team. This step will involve 5-10 participants from Phases 1 and 2, who have provided approval for future contact (see approved Future Contact form). Once 5 participants have successfully and safely completed the test protocol, we will proceed to Phase 4.

Other: Remote Assessment of Physical Function

Phase IV

This phase is the same as Phase 3, except it includes newly enrolled participants, i.e., representing the first-time participants have enrolled/participated in this study. This will eliminate the practice effect that will occur in phase 3. This step will enroll 5-10 participants.

Other: Remote Assessment of Physical Function

Interventions

Remote Assessment of Physical Function with Direct Observation OTHER

An android tablet with Wi-Fi and cellular will be used to compare videoconferencing with face-to-face assessment of 2 timed, physical performance tests. The physical performance tests include the 30-second chair stand test (30s-CST) and the Timed Up \& Go (TUG) test. The TUG test is measured as the time to stand from a standard arm chair, walk 10 feet, turn around, return to start and sit down. The 30s-CST is measured as the number of times a person comes to a full standing position from a chair in 30 seconds, as quickly as possible, without using ones' hands.

Phase I; Phase II

Remote Assessment of Physical Function OTHER

An android tablet with Wi-Fi and cellular will be mailed to study participants to remotely assess 2 timed, physical performance tests. The physical performance tests include the 30-second chair stand test (30s-CST) and the Timed Up \& Go (TUG) test. The TUG test is measured as the time to stand from a standard arm chair, walk 10 feet, turn around, return to start and sit down. The 30s-CST is measured as the number of times a person comes to a full standing position from a chair in 30 seconds, as quickly as possible, without using ones' hands.

Phase III; Phase IV

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older cancer survivors

You may qualify if:

• Residence in New Mexico
• Previous diagnosis of cancer, completed primary treatment (surgery, radiation, chemotherapy), and not currently being treated for a recurrence.
• Mild-to-moderate physical functional impairment (≥2 functions limited a lot or limited a little on the Short Form 36-item Physical Function Subscale)
• Able to speak, read, \& understand English
• Participating in less than 120 minutes per week of moderate-to-vigorous intensity physical activity
• Living independently and capable of walking 3 blocks without stopping to rest.
• Availability of a family member or friend to be present (for safety) during remote assessment of performance tests (Phases III and IV only)
• No severe impairments or pre-existing medical limitations for engaging in daily light-intensity physical activity (e.g., severe orthopedic conditions, pending hip/knee replacement, chronic vertigo, dementia)
• No severe hearing or vision deficits that would inhibit communication with the research team via videoconferencing and tablet use.
• Willing to use a tablet computer and videoconferencing software to communicate with a study team member during the assessment.
• Enough space (14 feet by 3 feet) to safely conduct the physical function tests.
• Not at high risk for falls

Sponsors & Collaborators

• University of New Mexico: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (1)

• Blair CK, Harding E, Herman C, Boyce T, Demark-Wahnefried W, Davis S, Kinney AY, Pankratz VS. Remote Assessment of Functional Mobility and Strength in Older Cancer Survivors: Protocol for a Validity and Reliability Study. JMIR Res Protoc. 2020 Sep 1;9(9):e20834. doi: 10.2196/20834.

  PMID: 32769075 DERIVED

Results Point of Contact

• Title: Dr. Cindy Blair
• Organization: University of New Mexico

CiBlair@salud.unm.edu

15059257907

Study Officials

• Cindy K Blair, PhD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 9, 2020
• Study Start: November 20, 2019
• Primary Completion: November 13, 2021
• Study Completion: November 13, 2021
• Last Updated: May 24, 2024
• Results First Posted: March 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)