Mechanistic Effects of Health Coaching to Reduce Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations

Mechanistic Effects of Health Coaching to Reduce COPD Hospitalizations

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03837847

Enrollment

Registered

2019-02-12

Start date

2018-07-05

Completion date

2023-06-14

Last updated

2024-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Emphysema

Keywords

Health coaching

Brief summary

The researchers are trying to explore the benefit of Health Coaching on patients with severe symptoms of COPD.

Interventions

BEHAVIORALHealth Coaching Calls

Participants in this group will receive 12 weekly health coaching calls

BEHAVIORALControl

Participants in this group will receive 6 educational guides

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Masking description

It is not possible to blind the participants or the study team as subjects will know if they are receiving a health coaching call.

Intervention model description

Randomized Control wait design

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

Men and women 40 years or older with a clinical diagnosis of COPD with shortness of breath. Exclusion: terminal illness, inability to communicate by phone

Design outcomes

Primary

Measure	Time frame	Description
Change in Chronic Respiratory Questionnaire (CRQ) Fatigue Score	Baseline, 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.
Change in Chronic Respiratory Questionnaire (CRQ) Dyspnea Score	Baseline, 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.
Change in Chronic Respiratory Questionnaire (CRQ) Mastery Score	Baseline, 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.
Change in Chronic Respiratory Questionnaire (CRQ) Emotions Score	Baseline, 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.

Secondary

Measure	Time frame	Description
Change in Depression	Baseline, 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.
Change in Daily Physical Activity	Baseline,3 months	Mean change in the number of steps per day
Change in Anxiety	Baseline,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.
Change in Self Management	Baseline, 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.
Change in Meaning in Life Questionnaire (MLQ) - Presence of Meaning	Baseline, 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.
Change in Meaning in Life Questionnaire (MLQ) - Search for Meaning	Baseline, 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

Countries

United States

Participant flow

Participants by arm

Arm	Count
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	33
Health Coaching Participants in this group received health coaching calls Health Coaching Calls: Participants in this group received 12 weekly health coaching calls	30
Total	63

Baseline characteristics

Characteristic	Health Coaching	Total	Control Group
Age, Continuous	69.410 years STANDARD_DEVIATION 6.3	68.828 years STANDARD_DEVIATION 8.129	68.301 years STANDARD_DEVIATION 9.562
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	2 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants	59 Participants	31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	2 Participants	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	5 Participants	6 Participants	1 Participants
Race (NIH/OMB) More than one race	1 Participants	2 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	3 Participants	1 Participants
Race (NIH/OMB) White	22 Participants	52 Participants	30 Participants
Region of Enrollment United States	30 participants	63 participants	33 participants
Sex: Female, Male Female	16 Participants	37 Participants	21 Participants
Sex: Female, Male Male	13 Participants	24 Participants	11 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	3 / 33	2 / 30
other Total, other adverse events	0 / 33	0 / 30
serious Total, serious adverse events	0 / 33	0 / 30

Outcome results

Primary

Change in Chronic Respiratory Questionnaire (CRQ) Dyspnea Score

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.

Time frame: Baseline, 3 months