Development of the intervention programme

As previously described, the ‘ABLE 1.0’ programme was developed based on a review of theory and scientific evidence as well as two studies gathering information about clinical experience and needs and expectations of persons living with chronic conditions. As previous studies have supported the use of the Occupational Therapy Intervention Process Model (OTIPM) as the basis for designing interventions within occupational therapy,31–33 the programme is based on the present version of this theoretical model of the therapy process.17 The model includes: (A) evaluation of the participant’s self-reported and observed ADL ability, (B) individual goal setting, (C) implementation of interventions focused and/or based on performance of purposeful and meaningful everyday life tasks and (D) re-evaluation.

Moreover, the ‘ABLE 1.0’ programme is developed based on a scoping review by Hand et al 15 suggesting the following elements to be included in the interventions for persons with chronic diseases: (A) individualised programme (ie, individualised goal setting and problem solving), (B) family or peer support, (C) strategies to facilitate coping with ADL task performance and (D) promoting continued use of strategies. Furthermore, the interventions sessions are based on principles related to energy conservation.20 In previous studies, such principles have been implemented among various diagnostic groups, including persons with heart failure,21 chronic obstructive pulmonary disease (COPD),22 multiple sclerosis23 24 and persons with fatigue.25

Two studies have been conducted to further inform the intervention programme. That is, one study investigating the self-reported ADL ability in men and woman living with various chronic conditions (schizophrenia, COPD, cancer and rheumatological diseases).26 The results of this study indicated which ADL tasks that persons living with chronic conditions perceive problems performing and also what kind of problems (ie, decreased safety, increased use of time and effort and need for assistance). The results revealed that persons living with chronic conditions predominantly perceive problems related to increased use of time and increased physical effort during ADL task performance. Thus, the findings led to designing intervention components based on energy conservation principles (eg, dividing the specific task into minor parts) to decrease time use and physical effort.

The second study aimed at identifying ideas on how to enhance ADL ability according to persons with chronic conditions and occupational therapists.27 The ideas identified in the study were organised in themes related to applying new strategies and adaptation in everyday life, personal factors of the persons living with chronic conditions, social environment, including the support from others and relevant services and opportunities in general. Hence, these findings were used to develop and integrate intervention components based on the clinical expertise of the occupational therapists as well as the needs and expectations of persons living with chronic conditions. For example, the theme Adaptation resulted in designing components related to applying adaptive equipment or modifying the physical environment (eg, rearrangements in the kitchen).

A joint display34 was created to condense and translate the most central parts of the above-mentioned information into specific intervention components. Furthermore, during the development process, ‘The Logic Model Development Guide’ by W.K. Kellogg Foundation35 was used as frame of reference to develop both a basic logic model and a theory-of-change logic model. Furthermore, two half-day workshops were conducted with 6 months in between, where authors of this paper were present to discuss and revise preliminary versions of the intervention programme.

Duration and specific content of the intervention programme

The ‘ABLE 1.0.’ is an 8-week intervention programme consisting of five to eight sessions: session 1: first meeting and occupational therapy evaluation (mandatory) involving a standardised ADL interview (ADL-Interview (ADL-I))36 37 and ADL observation (Assessment of Motor and Process Skills (AMPS))38 39; session 2: goal setting using Goal Attainment Scaling (GAS)40 41 and clarification of reasons for ADL task performance problems (mandatory); sessions 3–7: interventions aiming at enhancing ADL ability are enacted based on information from the first two sessions (the number of intervention sessions can vary, but a minimum of two sessions is mandatory) and session 8: re-evaluation (mandatory) including evaluation of goal attainment based on GAS.

Overall, an adaptational approach is being applied, and the interventions are focused and/or based on performance of purposeful and meaningful ADL tasks.17 More specifically, the intervention sessions are founded on ‘the compensatory model’ of the OTIPM and organised using the person–environment–occupation model.42 Thus, creating a ‘tool box’ including optional intervention components (for use in sessions 3–7) aiming at changing the person (eg, changing habits related to task performance), the environment (eg, changing physical and/or social environment) and/or the occupation (here ADL task) (ie, using task analysis to adjust the challenge of the task to the ability of the person by, e.g., dividing the task into minor parts in order to simplify the task). A total of nine optional intervention components were developed.

Central to the interventions is that these will be individually tailored (based on baseline evaluations) and implemented in natural/ecologic contexts, that is, where the participants typically perform ADL tasks (eg, home or local area) and with the tools and materials they usually use.17 The intervention sessions are based on face-to-face and/or telephone contact between the occupational therapist and the participant. Based on an agreement between the occupational therapist and the participant, the participants can be asked to do ‘homework’ between two intervention sessions (eg, trying out a new way of performing an ADL task).

Training of the intervention providers

The intervention will be provided by two occupational therapists employed at the municipality, with at least 2 years’ experience working with ADL problems among persons with chronic conditions, calibrated AMPS raters38 and willing to participate in training sessions, supervision and meetings.

To ensure uniformity and standardisation of the programme, a comprehensive manual describing the procedures, content of each session as well as the optional intervention components (the tool box) has been developed. Moreover, since training and ongoing supervision and communication is crucial when conducting intervention studies,31 43 the therapists involved in the intervention will participate in a 2.5-day training workshop before starting to deliver the intervention programme. The training workshop will contain introduction to the OTIPM, the intervention manual, cases with role play, video demonstrations (1 day), ADL-I training (half day) as well as overall introduction to research in general and specifically to data collection in the present study (1 day). During the intervention period, the occupational therapists will participate in meetings to receive supervision aiming at clarifying issues related to the programme, including application of the manual in clinical practice. The collaborative learning process will be facilitated by the interactions sharing experiences and reflections.43 The second author will be responsible for both the intervention-training sessions before the intervention period and for supervision during the intervention period. The last author will be responsible for teaching the ADL-I.

Feasibility data

A combination of qualitative and quantitative data will be collected among the occupational therapists and the participants using registration forms, as well as semistructured qualitative interviews (table 1). The aim of the interviews is to explore aspects of (A) perceived value, benefits, harms or unintended consequences of the intervention, (B) acceptability of the intervention and (C) fidelity, reach and dose of intervention28 according to occupational therapists and participants, respectively (table 1).

Outcomes data

As previous studies have revealed limited relationship between self-reported and observed ADL ability in persons with chronic conditions,5 6 the coprimary outcomes will be self-reported, and observed ADL ability measured at baseline and post intervention. Self-reported ADL ability is measured using the ADL-I36 37 and the observed ADL ability is measured using the AMPS.38 39 As previously mentioned, aside from being coprimary outcomes, baseline ADL-I and AMPS data will also form the basis for goal setting and intervention planning in the intervention process. Therefore, the baseline evaluations will be conducted by the occupational therapists, whereas trained and calibrated occupational therapy students not involved in the intervention will conduct postintervention re-evaluations. Secondary outcome will be goal attainment evaluated by the GAS.40 41

Demographic data

Demographic data characterising the participants living with chronic conditions will be collected as part of the occupational therapy evaluation by the occupational therapists at the first session of the ABLE programme (baseline): age, gender, diagnosis, years living with a chronic condition and self-reported general health.

General health

General health is assessed using the first question (SF1) of the Short Form 36 (SF36).46 The SF1 is a single question often used as an indicator of general health and well-being based on self-report. Thus, the following question will be asked: ‘In general, would you say your health is: Excellent, Very good, Good, Fair or Poor?’ Previous studies indicate that the question is applicable in persons with chronic conditions.46

Data on the two occupational therapists delivering the ABLE intervention (age, gender, years since graduation as occupational therapist and years working with persons with chronic conditions) will be collected at the first training session. Furthermore, the number of participants treated by each of the therapists will be collected.

Registration forms

After each session, occupational therapists and participants will independently fill out registration forms. The registration forms are developed to capture aspects related to (A) intervention development, (B) intervention components, (C) mechanisms of change, (D) perceived value, benefits, harms or unintended consequences of the intervention, (E) acceptability of intervention in principle, (F) feasibility and acceptability of intervention in practice and (G) fidelity, reach and dose of intervention28 (table 1). The participants will hand in their registration forms to the occupational therapists in closed envelopes after each session.

Outcomes

The occupational therapists delivering the intervention programme will perform baseline ADL-I and AMPS evaluations during the first week of the intervention programme, that is, at the first session (figure 1). Postintervention ADL-I and AMPS re-evaluations will be conducted in week 8, that is, during the last week of the intervention programme. These re-evaluations will be conducted by five pregraduate occupational therapy students calibrated as AMPS raters38 and willing to participate in training session related to the ADL-I. The students have no personal or professional relation to the municipality, the occupational therapists involved in the interventions or the participants receiving the interventions. The occupational therapy students will undergo three training sessions involving overall introduction to data collection in the present study (2–3 hours) as well as specific training related to performing ADL interviews (3 hours). The second and last author will be responsible for these training sessions.

The ADL-I, version 2.0 36 is a standardised evaluation tool used by occupational therapists to describe and measure the self-reported quality of ADL task performance in 47 ADL items in terms of physical effort and/or fatigue, efficiency, safety and independence. The following seven response categories are used: (A) I perform the task independently without use of extra time or effort and without risk; (B) I perform the task independently, but I use helping aids; (C) I perform the task independently, but it takes me extra time; (D) I perform the task independently, but I use extra effort/get tired; (E) I perform the task independently, but there is a risk that I might injure myself; (F) I need assistance from someone but do participate; and (G) the task is performed by others for me – I cannot participate actively.

The participant can mark more than one response category if several apply to his or her performance of the specific ADL task (eg, mark both categories C and D if they spend extra time and get tired). To create an overall measure of self-reported quality of ADL task performance, the mark given in the lowest response category on each task is rated using a four-point ordinal quality of performance scale: 4=‘competent’ (categories A/B), 3=‘extra time/effort’ (categories C/D), 2=‘safety risk/need help’ (categories E/F) and 1=‘unable’ (category G). Furthermore, the participant is to rate his or her perceived satisfaction with the quality of each ADL task performance using a four-point ordinal satisfaction scale: 4=‘very satisfied’, 3=‘satisfied’, 2=‘dissatisfied’ and 1=‘very dissatisfied’.37

The baseline ordinal quality of performance and satisfaction scores will form the basis for identification of ADL task performance problems to be prioritised at goal setting.37 To measure change in self-reported quality of ADL task performance, the 47 ordinal quality of performance scores are transformed into one overall linear (interval scale) measure of self-reported quality of ADL task performance, adjusted for the difficulty of the ADL tasks, based on Rasch measurement methods.36 The measures are expressed in logits (log-odds probability units).6 36 Previous studies indicate that the ADL-I can be used to generate valid and reliable linear measures of self-reported quality of ADL task performance among persons with chronic conditions.3 5 36

The AMPS 38 39 is a standardised observation-based evaluation tool used by occupational therapists to measure a person’s observed quality of ADL task performance in terms of physical effort and/or fatigue, efficiency, safety and independence. The person being evaluated chooses and performs at least two of the standardised ADL tasks that the person finds relevant and of appropriate challenge. During an AMPS evaluation, two domains of occupational performance are evaluated: motor skills (16 items) and process skills (20 items). After the observation, the quality of each skill is evaluated on a four-point ordinal scale according to the scoring criteria in the AMPS manual.39

The available AMPS software,47 based on Many-Faceted Rasch statistics, makes it possible to convert the ordinal raw scores into overall linear ADL motor and ADL process ability measures adjusted for task challenge, skill item difficulty and rater severity. The measures are expressed in logits (log-odds probability units).38 Several studies support that the AMPS ability measures are reliable and valid among persons with chronic conditions.5 6 48–50

GAS 40 41 is a tool for defining and monitoring a person’s individual goals. The person is actively involved in defining goals and describing the levels of goal attainment. When a goal is being defined, measurable and observable indicators, that is, indicators that can be used to evaluate the progress towards the goal (eg, independence, duration and frequency), are applied. The level of goal attainment is described using a scale from −2 to +2. The actual level of performance is described at level −1, and the expected level is described at level 0. Level +1 and level +2 are descriptions of what the person will be able to, if he or she achieves more than expected. Level −2 describes the level, where the person achieves less than expected.

A feasibility study51 concluded that GAS was applicable among older adults with multiple chronic conditions living at home.

Semistructured qualitative interviews

Semistructured qualitative interviews will be conducted by an occupational therapist not involved in developing and delivering the intervention programme. Participants and occupational therapists will be invited to participate in individual interviews.

Feasibility of the intervention: registrations forms

Descriptive statistical analyses will be conducted based on data recordings from the occupational therapists and participants (table 1).

The number of persons being recruited will be presented in a flow chart; the retention rate and the adherence to intervention manual will be presented based on frequencies and percentages. Based on registrations of time use at each session of the programme for each participant, the mean number of minutes used for each session will be presented. The number of participants seen by each occupational therapist will be presented based on frequencies and percentages. Furthermore, conditions facilitating and/or hindering the delivery of the sessions and potential positive and/or negative side effects will be registered by the occupational therapist and presented. The perceived degree of, for example, participant involvement, meaningfulness and confidence in relation to intervention delivery will be presented based on the occupational therapists’ ratings on visual analogue scale (VAS) from 1 to 5.

To which extent the participants perceived that they were informed, involved and on their way towards goal attainment will be presented based on the participants’ ratings on VAS from 1 to 5. Furthermore, the perceived meaningfulness and satisfaction will be rated and potential positive and/or negative side effects will be registered and presented.

Feasibility of the intervention: qualitative interviews

Interviews will be transcribed verbatim. A method of constant comparison28 52 will be used to analyse the semistructure interviews describing: (A) perceived value, benefits, harms or unintended consequences of the intervention, (B) acceptability of intervention in practice and (C) fidelity, reach and dose of intervention (table 1).

Evaluation of outcomes

The proportion of participants with a change in ADL ability measures (AMPS and ADL-I) will be identified. Thus, in accordance with the AMPS manual, the proportion of participants with no change (<0.3 logits), a clinically relevant increase (≥0.3 logits) or decrease (≥−0.3 logits) in AMPS ADL motor and/or ADL process ability measure will be identified.38 A criterion of 0.5 SD has previously been applied for evaluation of clinically relevant differences in measures based on self-report in persons with chronic pain.53 As chronic pain often derives from a chronic condition, the criterion of 0.5 SD is also applied in the present study. Thus, the proportion of participants with no change (change in logits equal to <0.5 SD as measured at baseline), a decrease or an increase in logits equal to ≥0.5 SD on the ADL-I ability measures will also be identified.