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NCT01263678 · ClinicalTrials.gov registry record · NA

Helping Patients With Spinal Stenosis Make a Treatment Decision: A Randomized Study Assessing The Benefits of Health Coaching

A NA study, sponsored by Dartmouth-Hitchcock Medical Center.

Completed
Registry status
NA
Development phase
199
Enrollment target

NCT01263678: Completed NA study, sponsored by Dartmouth-Hitchcock Medical Center.

NCT01263678 is a NA study that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 199 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01263678, a NA study, has completed, sponsored by Dartmouth-Hitchcock Medical Center.

COMPLETED
Registry status
NA
Development phase
199 participants
Enrollment target

Study Summary

Treatment options for lumbar spinal stenosis include surgical and non-surgical approaches. For most people, the decision depends on how bothered they are by their symptoms and how they feel about having surgery. Since individuals with the same clinical presentation may feel differently about their symptoms and how they view the benefits and harms of their options, there is no agreed upon "best"treatment. It has been shown that, for "preference-sensitive" decisions like this one, decision aids (tools that pair balanced, evidence-based information regarding treatment options with values clarification) improve patients'knowledge and realistic expectations, lower decisional conflict, increase patient involvement in decision making, decrease the number of undecided, and increase agreement between values and choice.1 The Spine Center, in collaboration with the Center for Shared Decision Making (CSDM) at Dartmouth Hitchcock Medical Center (DHMC), has been providing patients with decision aids (DAs) for several years. Hypothesis: Patients identified as having low literacy and/or high decisional conflict after viewing a video decision aid will show greater resolution of their decisional conflict, higher decision self-efficacy and less decision regret if a coaching intervention is paired with a video decision aid. Decision support in the form of coaching develops patients'skills in preparing for a consultation and deliberating about their options.2 A study of women with abnormal uterine bleeding showed that pairing coaching with a DA helped patients clarify their values and preferences, reduced costs, and increased long term satisfaction.3 The investigators plan to assess the impact of coaching in patients with lumbar spinal stenosis who are referred to the CSDM for a video decision aid about their treatment options. The investigators are also interested to learn whether screening for low literacy and high decisional conflict can identify a subgroup of patients who are mor

Primary Outcome

1. Assess the impact of decision coaching, following a specialty consultation for lumbar spinal stenosis, on levels of decisional conflict. 2. Assess the impact of decision coaching on decision self-efficacy, the number of treatment decision-related clinical contacts, treatment follow-through and decision regret. 3. Determine whether we can develop a tool that will allow us to identify patients most likely to benefit from coaching and develop a process to provide coaching to patients who need he

Interventions

  • OTHER Usual Care
  • BEHAVIORAL Coaching

Trial Details

FieldValue
Enrollment Target 199 participants
Start Date 2010-11
Est. Completion 2013-05
Phase NA
Dartmouth-Hitchcock Medical Center

427 total trials

What the finished NCT01263678 record still lists

NCT01263678 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 2 interventions - of which Usual Care is the first listed.

NCT01263678 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01263678 about?

NCT01263678 is a clinical study titled "Helping Patients With Spinal Stenosis Make a Treatment Decision: A Randomized Study Assessing The Benefits of Health Coaching". Treatment options for lumbar spinal stenosis include surgical and non-surgical approaches. For most people, the decision depends on how bothered they are by their symptoms and how they feel about having surgery. Since individuals with the same clinical presentation may feel differently about their s...

What is the current status of trial NCT01263678?

This trial is currently completed. It is a NA study. The enrollment target is 199 participants. The study started on 2010-11. Estimated completion is 2013-05.

What interventions are being tested in trial NCT01263678?

The interventions under investigation include: Usual Care (OTHER), Coaching (BEHAVIORAL).

Who is sponsoring clinical trial NCT01263678?

This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01263678's enrollment target sits among peer trials

199 567th of 2000 higher than 1,434 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01263678, the US trial registry maintained by the National Library of Medicine. NCT01263678 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.