Trial Outcomes & Findings for Mechanistic Effects of Health Coaching to Reduce Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations (NCT NCT03837847)

NCT ID: NCT03837847

Last Updated: 2024-07-11

Results Overview

The CRQ-Dyspnea is a 5-item questionnaire that assesses dyspnea on a Likert scale from 1 - 7. Higher scores indicate less severity of dyspnea.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 63 participants
• Primary outcome timeframe: Baseline, 3 months
• Results posted on: 2024-07-11

Participant Flow

Participant milestones

Measure	Control Group Participants in this group received 6 educational guides and 6 calls Control: Participants in this group received 6 educational guides and 6 calls to remind them to read the educational guides	Health Coaching Participants in this group received health coaching calls Health Coaching Calls: Participants in this group received 12 weekly health coaching calls
Overall Study STARTED	33	30
Overall Study COMPLETED	33	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age and Sex are unknown for one participant in each arm

Baseline characteristics by cohort

Measure	Control Group n=33 Participants Participants in this group received 6 educational guides and 6 calls Control: Participants in this group received 6 educational guides and 6 calls to remind them to read the educational guides	Health Coaching n=30 Participants Participants in this group received health coaching calls Health Coaching Calls: Participants in this group received 12 weekly health coaching calls	Total n=63 Participants Total of all reporting groups
Age, Continuous	68.301 years STANDARD_DEVIATION 9.562 • n=32 Participants • Age and Sex are unknown for one participant in each arm	69.410 years STANDARD_DEVIATION 6.300 • n=29 Participants • Age and Sex are unknown for one participant in each arm	68.828 years STANDARD_DEVIATION 8.129 • n=61 Participants • Age and Sex are unknown for one participant in each arm
Sex: Female, Male Female	21 Participants n=32 Participants • Age and Sex are unknown for one participant in each arm	16 Participants n=29 Participants • Age and Sex are unknown for one participant in each arm	37 Participants n=61 Participants • Age and Sex are unknown for one participant in each arm
Sex: Female, Male Male	11 Participants n=32 Participants • Age and Sex are unknown for one participant in each arm	13 Participants n=29 Participants • Age and Sex are unknown for one participant in each arm	24 Participants n=61 Participants • Age and Sex are unknown for one participant in each arm
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=33 Participants	1 Participants n=30 Participants	2 Participants n=63 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=33 Participants	28 Participants n=30 Participants	59 Participants n=63 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=33 Participants	1 Participants n=30 Participants	2 Participants n=63 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=33 Participants	0 Participants n=30 Participants	0 Participants n=63 Participants
Race (NIH/OMB) Asian	0 Participants n=33 Participants	0 Participants n=30 Participants	0 Participants n=63 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=33 Participants	0 Participants n=30 Participants	0 Participants n=63 Participants
Race (NIH/OMB) Black or African American	1 Participants n=33 Participants	5 Participants n=30 Participants	6 Participants n=63 Participants
Race (NIH/OMB) White	30 Participants n=33 Participants	22 Participants n=30 Participants	52 Participants n=63 Participants
Race (NIH/OMB) More than one race	1 Participants n=33 Participants	1 Participants n=30 Participants	2 Participants n=63 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=33 Participants	2 Participants n=30 Participants	3 Participants n=63 Participants
Region of Enrollment United States	33 participants n=33 Participants	30 participants n=30 Participants	63 participants n=63 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months

Population: Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months

The CRQ-Dyspnea is a 5-item questionnaire that assesses dyspnea on a Likert scale from 1 - 7. Higher scores indicate less severity of dyspnea.

Outcome measures

Measure	Health Coaching n=22 Participants Participants in this group received health coaching calls Health Coaching Calls: Participants in this group received 12 weekly health coaching calls	Control Group n=24 Participants Participants in this group received 6 educational guides
Change in Chronic Respiratory Questionnaire (CRQ) Dyspnea Score	0.29 score on a scale Interval -0.02 to 0.59	-0.26 score on a scale Interval -0.66 to 0.14

PRIMARY outcome

Timeframe: Baseline, 3 months

Population: Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months

The CRQ-Fatigue is a 4-item questionnaire that assesses fatigue on a Likert scale from 1 - 7. Higher scores indicate less severity of fatigue.

Outcome measures

Measure	Health Coaching n=22 Participants Participants in this group received health coaching calls Health Coaching Calls: Participants in this group received 12 weekly health coaching calls	Control Group n=24 Participants Participants in this group received 6 educational guides
Change in Chronic Respiratory Questionnaire (CRQ) Fatigue Score	0.53 score on a scale Interval -0.05 to 1.12	0.33 score on a scale Interval 0.04 to 0.7

PRIMARY outcome

Timeframe: Baseline, 3 months

Population: Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months

The CRQ-Mastery is a 4-item questionnaire that assesses mastery on a Likert scale from 1 - 7. Higher scores indicate a higher level of mastering the ability to deal with the symptoms of the disease.

Outcome measures

Measure	Health Coaching n=22 Participants Participants in this group received health coaching calls Health Coaching Calls: Participants in this group received 12 weekly health coaching calls	Control Group n=24 Participants Participants in this group received 6 educational guides
Change in Chronic Respiratory Questionnaire (CRQ) Mastery Score	0.4 score on a scale Interval -0.22 to 1.02	0.22 score on a scale Interval 0.12 to 0.56

PRIMARY outcome

Timeframe: Baseline, 3 months

Population: Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months

The CRQ-Emotions is a 7-item questionnaire that assesses emotions on a Likert scale from 1 - 7. Higher scores indicate less severity of emotions.

Outcome measures

Measure	Health Coaching n=22 Participants Participants in this group received health coaching calls Health Coaching Calls: Participants in this group received 12 weekly health coaching calls	Control Group n=24 Participants Participants in this group received 6 educational guides
Change in Chronic Respiratory Questionnaire (CRQ) Emotions Score	0.35 score on a scale Interval 0.06 to 0.76	0.25 score on a scale Interval 0.06 to 0.55

SECONDARY outcome

Timeframe: Baseline,3 months

Population: Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months

Mean change in the number of steps per day

Outcome measures

Measure	Health Coaching n=22 Participants Participants in this group received health coaching calls Health Coaching Calls: Participants in this group received 12 weekly health coaching calls	Control Group n=24 Participants Participants in this group received 6 educational guides
Change in Daily Physical Activity	174.25 steps per day Interval -794.96 to 1143.46	-107.88 steps per day Interval -688.47 to 472.72

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months

Self-Management Ability Scale-30 item questionnaire measuring ability and function. Total score range is 0-100, higher score indicated better ability and function.

Outcome measures

Measure	Health Coaching n=22 Participants Participants in this group received health coaching calls Health Coaching Calls: Participants in this group received 12 weekly health coaching calls	Control Group n=24 Participants Participants in this group received 6 educational guides
Change in Self Management	1.78 score on a scale Interval -2.89 to 6.45	-0.7 score on a scale Interval -4.42 to 3.02

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months

The MLQ is a 10-item questionnaire that assesses quality of life rated on a seven-point scale from 1 = Absolutely Untrue to 7 =Absolutely True. The Presence of Meaning subscale score = subtract the rating for item #9 from 8, then add to the ratings for items 1, 4, 5, and 6. Total Presence of Meaning Scores range between 5 and 35. Higher scores indicate more fullness of meaning a person feels in their life.

Outcome measures

Measure	Health Coaching n=22 Participants Participants in this group received health coaching calls Health Coaching Calls: Participants in this group received 12 weekly health coaching calls	Control Group n=24 Participants Participants in this group received 6 educational guides
Change in Meaning in Life Questionnaire (MLQ) - Presence of Meaning	-0.43 score on a scale Interval -3.94 to 3.08	0.32 score on a scale Interval -1.86 to 2.5

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months

The MLQ is a 10-item questionnaire that assesses quality of life rated on a seven-point scale from 1 = Absolutely Untrue to 7 =Absolutely True. The Search for Meaning subscale score = add together the ratings for items 2, 3, 7, 8, and 10. Total Search for Meaning scores range between 5 and 35. Higher scores indicate more engaged and motivated a person feels to understand and find meaning in their life

Outcome measures

Measure	Health Coaching n=22 Participants Participants in this group received health coaching calls Health Coaching Calls: Participants in this group received 12 weekly health coaching calls	Control Group n=24 Participants Participants in this group received 6 educational guides
Change in Meaning in Life Questionnaire (MLQ) - Search for Meaning	2.38 score on a scale Interval -2.36 to 7.13	-1.45 score on a scale Interval -3.87 to 0.97

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months

The Patient Health Questionnaire 9-item (PHQ-9) scale used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression.

Outcome measures

Measure	Health Coaching n=22 Participants Participants in this group received health coaching calls Health Coaching Calls: Participants in this group received 12 weekly health coaching calls	Control Group n=24 Participants Participants in this group received 6 educational guides
Change in Depression	-0.57 score on a scale Interval -3.19 to 2.05	0.13 score on a scale Interval -1.97 to 2.24

SECONDARY outcome

Timeframe: Baseline,3 months

Population: Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months

The General Anxiety Disorder 2-item (GAD 2) scale assess severity of generalized anxiety disorder. Total scores range from 0-6, a higher score indicates greater anxiety.

Outcome measures

Measure	Health Coaching n=22 Participants Participants in this group received health coaching calls Health Coaching Calls: Participants in this group received 12 weekly health coaching calls	Control Group n=24 Participants Participants in this group received 6 educational guides
Change in Anxiety	0.27 score on a scale Interval -0.63 to 1.17	0.05 score on a scale Interval -0.7 to 0.79

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Health Coaching

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roberto P. Benzo, M.D.

Mayo Clinic

Phone: 507-284-0561

Email: Benzo.Roberto@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place