Trial Outcomes & Findings for Illness Management and Recovery Treatment Integrity Scale Validation and Leadership Intervention Development (NCT NCT02431299)

Results Overview

Post-intervention scores were assessed. This measure is designed to assess consumer-rated illness self management skills. This scale is based on a 15 items, each rated on a 5 point Likert scale, ranging from 1 to 5. Higher numbers of this scale represent better outcomes. A mean score of all 15 items is provided as the primary outcome score for this scale.

Recruitment status

COMPLETED

Target enrollment

299 participants

Primary outcome timeframe

3-Months

Results posted on

2015-12-23

Participant Flow

Participant milestones

Participant milestones
Measure	IMR Consumers Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.	IMR Clinicians The clinicians who provided IMR intervention to the IMR Consumers
Overall Study STARTED	236	63
Overall Study COMPLETED	183	62
Overall Study NOT COMPLETED	53	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Illness Management and Recovery Treatment Integrity Scale Validation and Leadership Intervention Development

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IMR Consumers n=236 Participants Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.	IMR Clinicians n=62 Participants Clinicians who provided the IMR intervention to the IMR Consumers	Total n=298 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	231 Participants n=5 Participants	61 Participants n=7 Participants	292 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Gender Female	90 participants n=5 Participants	41 participants n=7 Participants	131 participants n=5 Participants
Gender Male	128 participants n=5 Participants	21 participants n=7 Participants	149 participants n=5 Participants
Region of Enrollment United States	236 participants n=5 Participants	62 participants n=7 Participants	298 participants n=5 Participants
Illness Management and Recovery Scale	3.55 units on a scale STANDARD_DEVIATION .6 • n=5 Participants	NA units on a scale STANDARD_DEVIATION NA • n=7 Participants	3.55 units on a scale STANDARD_DEVIATION .6 • n=5 Participants
Working Alliance Inventory Short Form	5.65 units on a scale STANDARD_DEVIATION 1.0 • n=5 Participants	NA units on a scale STANDARD_DEVIATION NA • n=7 Participants	5.65 units on a scale STANDARD_DEVIATION 1.0 • n=5 Participants
Multidimensional Scale of Perceived Social Support	4.94 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants	NA units on a scale STANDARD_DEVIATION NA • n=7 Participants	4.94 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants
Adult State Hope Scale	18.8 units on a scale STANDARD_DEVIATION 3.7 • n=5 Participants	NA units on a scale STANDARD_DEVIATION NA • n=7 Participants	18.8 units on a scale STANDARD_DEVIATION 3.7 • n=5 Participants
Medication Adherence Rating Scale	2.45 units on a scale STANDARD_DEVIATION .12 • n=5 Participants	NA units on a scale STANDARD_DEVIATION NA • n=7 Participants	2.45 units on a scale STANDARD_DEVIATION .12 • n=5 Participants
UNCOPE	1.88 units on a scale STANDARD_DEVIATION .13 • n=5 Participants	NA units on a scale STANDARD_DEVIATION NA • n=7 Participants	1.88 units on a scale STANDARD_DEVIATION .13 • n=5 Participants
Brief COPE Inventory Adaptive Coping Subscale	5.64 units on a scale STANDARD_DEVIATION 1.4 • n=5 Participants	NA units on a scale STANDARD_DEVIATION NA • n=7 Participants	5.64 units on a scale STANDARD_DEVIATION 1.4 • n=5 Participants
Brief COPE Inventory Maladaptive Coping Subscale	4.46 units on a scale STANDARD_DEVIATION 1.2 • n=5 Participants	NA units on a scale STANDARD_DEVIATION NA • n=7 Participants	4.46 units on a scale STANDARD_DEVIATION 1.2 • n=5 Participants

PRIMARY outcome

Timeframe: 3-Months

Population: Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.

Post-intervention scores were assessed. This measure is designed to assess consumer-rated illness self management skills. This scale is based on a 15 items, each rated on a 5 point Likert scale, ranging from 1 to 5. Higher numbers of this scale represent better outcomes. A mean score of all 15 items is provided as the primary outcome score for this scale.

Outcome measures

Outcome measures
Measure	IMR Consumers n=183 Participants Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
Illness Management and Recovery Scale	3.72 units on a scale Standard Deviation 0.5

PRIMARY outcome

Timeframe: 3-Months

Clinician competency rating scale was used to assess clinician competence in providing IMR. This data was used to test the theory that IMR competency would impact consumers' ability to engage in illness self management practices as rated by the Illness Management and Recovery Scale. This scale is rated by trained observers, and the scale contains 16 items, rated on a 1 - 5 point scale. A 5 indicates higher competency and fidelity to the IMR treatment model. A mean score is calculated across all 16 items. Higher scores indicate higher clinician competence in providing IMR.

Outcome measures

Outcome measures
Measure	IMR Consumers n=63 Participants Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
Illness Management and Recovery Treatment Integrity Scale	2.73 units on a scale Standard Deviation .55

SECONDARY outcome

Timeframe: 3-Months

Population: Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.

This is a consumer rated scale indicated working alliance between consumer and clinician. The scale has 12 items, rated on a 7 point Likert style scale (ranging from 1-7). The total score provided a mean score of all 12 items. Better working alliance is indicated by a higher score.

Outcome measures

Outcome measures
Measure	IMR Consumers n=158 Participants Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
Working Alliance Inventory Short Form	5.58 units on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: 3-Months

Population: Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.

This scale is a consumer rated assessment of perceived social support systems. There are 12 items each rated on a 7 point Likert scale (ranging from 1-7). A mean score is calculated from all 12 items. Higher scores represent better outcomes (i.e. higher levels of perceived social support).

Outcome measures

Outcome measures
Measure	IMR Consumers n=183 Participants Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
Multidimensional Scale of Perceived Social Support	5.18 units on a scale Standard Deviation .11

SECONDARY outcome

Timeframe: 3-Months

Population: Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.

This is a consumer rated measure that assesses the level of goal related hope a consumer possesses. This version is a 6 item measure, with each item rated on a 4 point scale (range 1-4, with 1 being "Definitely False" and 4 being "Definitely True"). A summary score is calculated by summing all 6 items. Higher scores represent better outcomes (i.e. higher goal related hope). These summary scores were then averages to calculate a mean score for our sample.

Outcome measures

Outcome measures
Measure	IMR Consumers n=181 Participants Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
Adult State Hope Scale	19.13 units on a scale Standard Deviation 3.6

SECONDARY outcome

Timeframe: 3-Months

Population: Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.

This is a consumer rated assessment of adaptive coping skills. This is derived from the 28 item, full scale. The scale uses a 1-4 Likert scale, indicating the frequency of using different coping strategies. There are 14 subscales, each calculated by summing 2 items. The range on each subscale is 2 - 8. The 14 subscales are further combined into 2 larger scales - maladaptive and adaptive coping. Adaptive coping is calculated by averaging the responses from 8 out of the 14 subscales. Higher scores indicate better outcomes (i.e. higher use of adaptive coping strategies).

Outcome measures

Outcome measures
Measure	IMR Consumers n=183 Participants Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
Brief COPE Adaptive Subscale	5.73 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 3-Months

Population: Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.

This is a consumer rated scale assessing medication adherence. This is a 10 item scale with each question rated as "yes" or "no". A yes is assigned a value of 1. The scale ranges from 0 (no "yes" responses) to 10 (all "yes" responses endorsed). The total number of "yes" responses is totaled to create a summary score. The mean score is calculated based on averaging the summary scores for the entire consumer sample. Higher scores mean better outcomes for medication adherence.

Outcome measures

Outcome measures
Measure	IMR Consumers n=180 Participants Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
Medication Adherence Rating Scale	2.45 units on a scale Standard Deviation .15

SECONDARY outcome

Timeframe: 3-Months

Population: Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.

This meThis measure is a consumer rated substance abuse screener consisting of 6 "yes" or "no" questions. A response of "yes" is assigned a value of 1. The total number of "yes" responses are summed and a score of greater than 4 indicates likelihood of substance abuse. Higher scores mean worse outcomes for this scale (i.e. the higher the score, the greater the likelihood of substance abuse issues).

Outcome measures

Outcome measures
Measure	IMR Consumers n=174 Participants Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
UNCOPE Measure	.30 units on a scale Standard Deviation .03

SECONDARY outcome

Timeframe: 3-Months

Population: Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.

This is a consumer rated assessment of adaptive coping skills. This is derived from the 28 item, full scale. The scale uses a 1-4 Likert scale, indicating the frequency of using different coping strategies. There are 14 subscales, each calculated by summing 2 items. The range on each subscale is 2 - 8. The 14 subscales are further combined into 2 larger scales - maladaptive and adaptive coping. Maladaptive coping is calculated by averaging the responses from 6 out of the 14 subscales. Higher scores indicate worse outcomes (i.e. higher use of maladaptive coping strategies).

Outcome measures

Outcome measures
Measure	IMR Consumers n=183 Participants Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
Brief COPE Maladaptive Subscale	4.47 units on a scale Standard Deviation 1.1

Adverse Events

IMR Consumers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IMR Clinicians

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alan B. McGuire

Indiana University Purdue University Indianapolis

Phone: 3179882725

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place