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Any Musculoskeletal ConditionNCT07104305

Nudging and Relationship Building With Frequent Contact

A study testing High-contact communication strategy in people with Any Musculoskeletal Condition, run by University of Texas at Austin at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study aims to test in what way a care strategy incorporating frequent contact can benefit patients with musculoskeletal condition that necessitates some adaptation and resiliency to symptoms and limitations that are expected to be either long-lasting or permanent. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Any Musculoskeletal Condition
What is being tested?
High-contact communication strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Jan 2026to 1 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patient
  • New or return visit
  • English or Spanish speaker
  • A musculoskeletal condition that necessitates some adaptation and resiliency to symptoms and limitations that are expected to be either long-lasting or permanent

Who cannot join

  • Cognitive dysfunction
  • Language other than English or Spanish

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Texas Health Austin (UTHA)

    Austin, Texas, 78701

Other trials in United States

About this study

This study aims to test in what way a care strategy incorporating frequent contact can benefit patients with musculoskeletal condition that necessitates some adaptation and resiliency to symptoms and limitations that are expected to be either long-lasting or permanent.

Patients will be randomized into either group A, where they will receive the standard amount of contact with their clinician, or group B, in which they will have contact with their clinican more frequently.

The communication strategy may utilize text, email, portal, phone, video or other options as agreed on. The frequency will be at least once a week. All patients will complete a set of questionnaires at the end of the visit.

Read the detailed description

Irregular and uncomfortable bodily symptoms are common. Most are well adapted in a healthy life. People seek care when a symptom becomes a concern. Even the effort to attend a routine healthy check-up is usually based on not wanting to miss anything, which is accompanied by at least a slight concern that a problem might be found. People that are seeking care are unsettled to some degree.

This unsettled feeling is often rooted in or worsened by unhelpful thoughts (less effective cognitive coping strategies). An example of a less effective cognitive coping strategy is rumination on worst-case thoughts (catastrophic thinking). The unsettled feeling is worse when thoughts are perceived as facts (cognitive fusion). Cognitive fusion is greater when people are under greater stress or distress.

Clinicians can help people feel better and do more by gently correcting these misconceptions. And when correction of misconceptions is to some degree at odds with a person's experience of reality, expert advice may seem impersonal, dismissive, and uncaring.

Adherence to medical expertise is enhanced by a trusting relationship with one's clinicians. There are several methods for nurturing a clinician-patient relationship. One is to make small agreements or compromises such as ordering a test that is not likely to yield useful information, has a small risk of harm, and uses resources and doing so in the context of efforts to move towards more effective cognitive coping strategies and greater self-efficacy. Another is to use educational tools such as decision aids to depersonalize the transfer of expertise. A third approach is use more frequent contact to deepen the relationship.

This study posits that establishing a frequent-contact plan with a patient that might benefit from a healthier inner narrative can improve health using few resources other than clinician time, with a good patient experience compared to the typical single or infrequent in person specialist office visits.

Being tested
High-contact communication strategy
Keywords
Musculoskeletal, Orthopedics, Mental health, Patient-Clinician relationship
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-contact communication strategyBehavioural

    Patients will have contact with their clinician more frequently. The communication strategy may utilize text, email, portal, phone, video or other options as agreed on. The frequency will be at least once a week. All patients will complete a set of questionnaires at the end of the visit.

Study groups in NCT07104305
Study groupRoleWhat they receive
Standard careNo interventionPatients in this arm will receive the standard amount of contact with their clinician.
High-contact communication strategyExperimentalPatients will have contact with their clinician more frequently. The communication strategy may utilize text, email, portal, phone, video or other options as agreed on. The frequency will be at least once a week. All patients will complete a set of questionnaires at the end of the visit.
Receives: Behavioral: High-contact communication strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Guttman Satisfaction scale

    The Guttman Satisfaction Scale is a unidimensional questionnaire designed to measure the degree of patient satisfaction with the care they received. It consists of a series of hierarchically ordered yes/no items, with each successive item indicating a higher level of satisfaction. Total scores range from 0 to 7, with higher scores reflecting greater satisfaction, representing a better outcome.

    Measured: 1 month after enrollment

Secondary outcomes (5)
  1. PROMIS Physical Function CAT

    Patient-perceived physical function will be assessed using the PROMIS® Computer Adaptive Test (CAT) Physical Function v2.0. This instrument dynamically selects items from a calibrated item bank to measure physical functioning, including mobility, self-care, and instrumental activities. Scores are reported as T-scores, standardized with a mean of 50 and a standard deviation of 10 in the general U.S. population. Higher scores indicate better physical function and therefore a better outcome.

    Measured: 1 month after enrollment

  2. Negative Pain Thoughts Questionnaire (NPTQ-4)

    A shortened version (4 items) of the Negative Pain Thoughts Questionnaire will be used to assess maladaptive cognitive coping strategies related to pain. Each item is rated on a 5-point Likert scale (0 = never to 4 = always), with total scores ranging from 0 to 16. Higher scores indicate more frequent negative pain-related thoughts, representing a worse outcome.

    Measured: 1 month after enrollment

  3. PROMIS Depression CAT

    Patient-perceived feelings of depression will be assessed using the PROMIS Depression Computer Adaptive Test (CAT) v1.2. This instrument selects items from a validated item bank to measure negative mood, loss of interest, and feelings of hopelessness. Scores are reported as T-scores, standardized with a mean of 50 and a standard deviation of 10 in the general U.S. population. Higher scores indicate greater depressive symptoms, representing a worse outcome.

    Measured: 1 month after enrollment

  4. Jefferson Scale of Patient's Perceptions of Physician Empathy (JSPPE)

    The Jefferson Scale of Patient's Perceptions of Physician Empathy includes five items rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree), with total scores ranging from 5 to 35. Higher scores indicate greater perceived physician empathy, representing a better outcome.

    Measured: 1 month after enrollment

  5. Communication effectiveness

    Two questions will be used to assess patient-perceived communication effectiveness, focusing on clarity, understanding, and responsiveness during the clinical interaction. Each item was rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), with higher scores indicating more effective communication.

    Measured: 1 month after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2025
  2. Study start1 Jan 2026
  3. Primary completion1 Mar 2026
  4. Study completion1 Mar 2026

Why it stopped: Deemed not feasible to conduct at the current time.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
New or return patients with some opportunity to better adapt to a long-standing or permanent symptoms will be randomized to a high-contact communication strategy agreed on by the clinician and patient or standard care (the patient initiates between visit contact as needed). The communication strategy may utilize text, email, portal, phone, video or other options as agreed on. The frequency will be at least once a week. All patients will complete a set of questionnaires at the end of the visit. At the end of the initial visit and 1 month after enrollment, people will be contacted by their method of choice to repeat the questionnaires.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07104305
Sponsor's protocol ID
2019-07-0005
Status last verified
Jun 2026
First submitted
23 Dec 2019
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing High-contact communication strategy in people with Any Musculoskeletal Condition, run by University of Texas at Austin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Guttman Satisfaction scale (time frame: 1 month after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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